One-handed and double row methods for tissue fixation

ABSTRACT

Described herein is a simplified placement system and method for a tissue graft anchor by which a surgeon may introduce one or more sutures into a hole in a boney tissue, apply a precise amount of tension to the sutures to advance a soft tissue graft to a desired location, and then advance the anchor into the bone, preferably while maintaining the requisite pre-determined suture tension and without introducing spin to the suture. Particularly preferred embodiments allow for the one-handed operation, namely embodiments in which relative axial movement between the inner tensioning device and outer driver device is optionally physically constrained, for example by means of cooperating and/or compressive elements disposed in the respective hub and handle portions, are described herein. Other preferred embodiments of the present invention relate to multi-anchor constructs that may employ threaded implants exclusively, push-in implants exclusively, or a combination of threaded and push-in implants.

PRIORITY

This application is a continuation-in-part of U.S. patent applicationSer. No. 16/294,663 filed Mar. 6, 2019 (now U.S. Pat. No. 11,504,224),which, in turn, is a continuation-in-part of PCT Application No.PCT/US2017/050222 filed Sep. 6, 2017, which, in turn, claims priority toU.S. patent application Ser. No. 15/256,838 filed Sep. 6, 2016 (now U.S.Pat. No. 9,782,250 issued Oct. 10, 2017), which is acontinuation-in-part of U.S. patent application Ser. No. 15/012,060filed Feb. 1, 2016 (now U.S. Pat. No. 9,566,060 issued Feb. 14, 2017),which, in turn, is a continuation-in-part of U.S. patent applicationSer. No. 14/972,662 filed Dec. 17, 2015 (now U.S. Pat. No. 9,795,374issued Oct. 24, 2017), which, in turn, is a continuation of U.S. patentapplication Ser. No. 14/636,389 filed Mar. 3, 2015 (now U.S. Pat. No.9,226,817 issued Jan. 5, 2016), which, in turn, claims the benefit ofU.S. Provisional Application Ser. No. 61/966,744 filed Mar. 3, 2014;61/998,391 filed Jun. 26, 2014; 61/998,766 filed Jul. 7, 2014; and61/999,405 filed Jul. 26, 2014. The afore-mentioned PCT Application No.PCT/US2017/05022, to which the instant application claims priority as acontinuation-in part, also claims priority to U.S. patent applicationSer. No. 15/429,527 filed Feb. 10, 2017 (now U.S. Pat. No. 9,907,548issued Mar. 6, 2018). The contents of the afore-noted priorityapplications are hereby incorporated by reference in their entirety.

TECHNICAL FIELD OF THE INVENTION

The present invention relates generally to the field of endoscopic andarthroscopic surgery and suture anchor systems and devices for usetherein. More particularly, the invention relates to a knotless sutureanchor device utilized to secure soft tissue to bone or a boney surfaceto preclude the need to tie surgical knots to secure the tissue in placewith the device. Specifically, the invention relates to a simplifiedanchor system and method by which the surgeon may introduce one or moresutures into a hole in the bone, apply tension to the sutures to advancethe soft tissue to a desired location, and then advance the anchor intothe bone while maintaining the suture tension and graft position.

BACKGROUND OF THE INVENTION

The use of implants to affix tissue grafts to bone is well known in theorthopedic arts. Common procedures in which such implants are usedinclude, for example, the repair of rotator cuff tears, the repair oftorn ligaments in the knee, among others. In these procedures, a socketis drilled or punched in the bone at the attachment site and a graft issecured to the bone using an implant placed in the socket. The graft maybe secured to the implant by sutures, or, alternatively, an end of thegraft may be placed in the socket and secured directly by an implant.

In rotator cuff repair, implants commonly referred to as “anchors” areused. These anchors occur in two types: conventional anchors in whichthe suture is passed through the cuff after anchor placement, and“knotless” anchors in which the suture is passed through the cuff priorto anchor placement. In the former case, the graft is secured in placeby tying knots in the suture after it has been passed through the cuffso as to secure the cuff in the desired location. Conversely, as thename implies, when a knotless anchor is used, the sutures are passedthrough the cuff and through a feature of the anchor such that when theanchor is inserted into the socket, the suture position is secured bythe anchor. Accordingly, the tying of knots is not required. This isparticularly advantageous when performing endoscopic (arthroscopic)repairs since the tying of knots arthroscopically through a smalldiameter cannula can be difficult for some surgeons and, moreover, thereis an opportunity for tangling of the sutures.

Many anchors, both conventional and knotless, are supplied to thesurgeon mounted on a driver—a device that the surgeon uses to place theanchor in the prepared socket in the bone. In the case of threadedanchors, the driver has a form like that of a screwdriver, and indeedfunctions in the same manner. The proximal portion of the device forms ahandle that is grasped by the surgeon. Distal to the handle, an elongatedistal portion has formed at its distal end features for transmittingtorque to an implant. Some anchors, generally metallic anchors such as,for instance, the Revo® Suture Anchor by Conmed Corporation (Utica,N.Y.) and Ti-Screw Suture Anchor by Biomet Corporation (Warsaw, Ind.),have a protruding (male) proximal portion with a cross-section suitablefor transmitting torque (typically hexagonal or square) and a transverseeyelet formed therein. The driver for such devices has a complimentarysocket (female) formed in its distal end and a cannulation that extendsfrom the interior of the socket to the proximal handle portion of thedevice. Sutures loaded into the eyelet of the anchor extend through thedriver cannulation (or “lumen”) and are removably secured to the handleso as to retain the anchor in the socket of the driver. Such anchors arereferred to in the orthopedic arts as “pre-loaded”, meaning that suturescome loaded into an anchor that is ready for placement by the surgeonusing the associated driver.

Other threaded anchors have a socket (female) formed in their proximalends. Once again, the socket has a cross-section suitable fortransmitting torque that is typically polygonal, usually square orhexagonal. Typical of these are the V-LoX™ family of titanium sutureanchors by Parcus Medical (Sarasota, Fla.) and the ALLthread™ anchors byBiomet Corporation (Warsaw, Ind.). The drivers for such devices have aprotruding (male) torque-transmitting feature complementary to thesocket (female) formed in the proximal end of the anchor. These driversmay be cannulated to accommodate sutures that are preloaded into theanchor in the manner previously described, with the sutures being eitherfor the purpose of securing tissue after anchor placement, or for thepurpose of removably securing the anchor to the driver, wherein thesutures are released from the driver after the anchor is placed in thebone and subsequently removed and discarded so as to allow removal ofthe driver from the anchor. The depth of the socket in the proximal endof the implant must be sufficient to enable transmission of therequisite torque needed for anchor placement without deforming orfracturing the implant. As the maximum depth of the torque-transmittingportion is generally limited only by the configuration of the anchor, itis considered to be matter of design choice. Indeed, the implant mayhave a cannulation that extends axially through the implant as well as atorque-transmitting cross-section forming a substantial proximal portionor the entirety of the implant's length. Implants of the Bio-TenodesisScrew™ System by Arthrex, Inc have a cannulation with a constanttorque-transmitting cross-section, and are used with a driver having atorque-transmitting portion that extends beyond the distal end of theanchor, wherein the portion of the driver extending beyond the anchorand a suture loop in the driver cannulation are used together to insertthe end of a graft into a prepared socket prior to placement of theimplant.

Knotless suture anchor fixation is a common way of repairing soft tissuethat has been torn from bone. Illustrative examples of such “knotless”anchors include the Allthread™ Knotless Anchors by Biomet Incorporated(Warsaw, Ind.), the SwiveLock® Knotless Anchor system by Arthrex,Incorporated (Naples, Fla.), the HEALIX Knotless™ Anchors byDepuy/Mitek, Incorporated (Raynham, Mass.) and the Knotless Push-InAnchors such as the Knotless PEEK CF Anchor by Parcus Medical (Sarasota,Fla.). The procedure requires drilling or punching of holes into aproperly prepared boney surface. After suture has been passed throughsoft tissue, the suture anchor is introduced into the socket and driveninto the socket using a mallet or by screwing the anchor into the socketusing a driver device. These driver devices typically resemble ascrewdriver in form, having a proximal handle portion for applyingtorque or percussive force, and an elongate rigid distal portion havingat its distal end a torque or percussive force-transmittingconfiguration. In the case of torque-transmitting drivers used withthreaded anchors, the distal end of the driver typically has an elongatehexagonal or square distally extending portion that, through couplingwith a lumen in the anchor having a complementary cross-section,transmits torque to the anchor. The lumen may extend through anchor sothat the distal portion of the driver protrudes from the distal end ofthe anchor and rotates with the anchor during anchor placement.

Because the suture is drawn into the prepared socket along with theanchor during anchor placement, it is essential that a suitable lengthof suture extends between the graft and the anchor so that when theanchor is suitably positioned within the socket, the graft is properlypositioned. Determining the proper length of suture to allow between theanchor and the graft so as to achieve optimal graft positioning iscomplicated since suture(s) may twist (a process referred to in theorthopedic arts as “suture spin”) during anchor placement, therebyshortening the effective length and changing the final graft positionand/or undesirably increasing the suture tension.

U.S. Pat. No. 6,544,281 to ElAttrache et al. describes a cannulatedanchor placement system having a rotating inner member (which acts asthe driver) and a stationary outer member, wherein the rotating innermember serves to drive the threaded anchor. The rotating “driver”extends past the distal end of the anchor and is inserted into aprepared socket in the boney surface. A suture loop formed distal to thedistal end of the driver “captures” or “secures” sutures attached to agraft or the graft itself to the distal end of the driver. The distalend of the driver is then inserted into the socket to a proper depth foranchor placement thereby drawing the graft to the desired position priorto placement of the anchor. The anchor is then threaded into the socketto the predetermined depth. This system constitutes an improvement overother commercially available alternatives. However, because the graft orsutures are secured to or pass through the distal end of the rotatinginner (or “driver”), torque is transmitted not only to the anchor butalso to the graft or sutures attached thereto by the suture loop.Accordingly, twisting of the sutures or graft frequently occurs, therebychanging the resulting suture tension and/or the graft position (aprocess referred to in the orthopedic arts as “graft shift”).

U.S. Pat. No. 8,663,279 by Burkhart et al. describes a knotless anchorsystem similar in construction to that of ElAttrache et al. A “swivel”implant having formed therein an eyelet is releasably and pivotablymounted to the distal end of a driver distal portion that extendsdistally beyond the distal end of an anchor. After sutures are passedthrough the graft, they are threaded into the eyelet of the swivelimplant at the distal end of the driver. The distal end of the driverwith the swivel implant is then inserted into the socket. By pulling onthe suture tails, the graft is moved into position and secured byscrewing the anchor into the socket. However, because the sutures/graftare secured to the driver by means of the swivel eyelet implant, thetorque that may be transmitted to the sutures/graft is limited. However,torque transmission is not eliminated since the swivel implant isretained in the driver distal end by a suture loop under tension, whichextends through the cannula of the driver to the driver's proximal endwhere the suture ends are cleated. While an improvement over theElAttrache anchor system, suture spin is not eliminated in all cases,and indeed, cannot be since the suture-retaining implant is mounted tothe driver, which rotates during anchor placement. As such, some levelof torque transmission due to friction between the driver distal end andthe swivel eyelet implant is inevitable.

Other knotless anchors such as the ReelX STT™ Knotless Anchor System byStryker® Corporation (Kalamazoo, Mich.) and PopLok® Knotless Anchors byConMed Corporation (Utica, N.Y.) have complex constructions and requirethat the surgeon perform a sequence of steps to achieve a successfulanchor placement with the desired suture tension and proper cuffposition. The sequence of steps adds to procedure time and createsopportunities for failure of the placement procedure if a step is notperformed properly.

Accordingly, there is a need in the orthopedic arts for a knotlessanchor system that allows the surgeon to establish the graft position,and, while maintaining that position, place the anchor without changingthe suture tension or causing a shift in the graft position due tosuture spin. Furthermore, if the anchor is threaded, placement of theanchor in the socket must occur without spinning of the suture.

In cases where a graft, such as a biceps tendon, is to be directlyaffixed to a bone by insertion of the graft into a socket (a techniquereferred to in the art as “bio-tenodesis”), it is essential that thegraft be fully inserted into the socket so as to be engaged by the fulllength of the implant. It is also important that the position of thegraft be maintained during anchor insertion. Further, it is essentialthat the alignment of the implant (referred to in this case as an“interference screw”) be coaxial, or if slightly shifted, parallel tothe axis of the socket. It is also desirable that the sutures used todraw the graft into the socket do not spin or twist during anchorplacement as this may change the position and tension of the graft fromthat intended by the surgeon. In sum, there is also a need in the suturearts for an interference screw and implant placement system in whichgraft position within the socket is maintained throughout the implantplacement process, and in which suture spin or twisting is prevented.

SUMMARY OF THE INVENTION

A primary objective of the present invention is to provide improvedmeans and methods of attaching soft tissues (i.e., “grafts”) to bone insitu. The embodiments of the present invention described hereinbelowrelate to a system and method for the placement of a simple one-piececannulated anchor or for producing a matrix of implants for theanchoring of a graft to bone. Any graft fixation system that uses animplant placement system with an optionally cannulated, non-rotatingtensioning device (i.e., the relatively fixed “inner assembly”)positioned within a cannulation or “lumen” of a cannulated driver (i.e.,the relatively movable “outer assembly”) to tension sutures in aprepared socket for the placement of a simple one-piece cannulatedanchor are contemplated by the present invention. Illustrative aspectsand embodiments of the present invention in accordance with theforegoing objective are as follows:

In a first aspect, the present invention provides prosthetic implantsand systems for their placement in a target boney surface for theknotless securing of a soft tissue graft thereto. The present inventioncontemplates a novel placement system including a non-rotating,cannulated tensioning device (“inner assembly”) positioned within arotationally and axially movable cannulated driver (“outer assembly”).In a preferred embodiment, a tubular distal element of the tensioningdevice extends distally beyond the distal end of the cannulated driver.A cannulated threaded implant (or “anchor”) is removably mounted to thetorque-transmitting distal portion of the driver. Sutures placed in thegraft are drawn into the distal end of the elongate distal portion ofthe cannulated tensioning device, which extends beyond the distal end ofthe implant. If a threaded implant is used, the distal end of thecannulated driver preferably includes torque-transmitting features that,together with complementary features formed in the proximal portion ofthe implant or anchor, allow the transmission of torque thereto. If aninterference plug-type anchor is used, the distal end of the driver ispreferably configured to transmit axial force to the anchor, theproximal end of which has a suitably complementary configuration toenable secure attachment.

In operation, sutures placed in the graft are drawn into the distal endof the tensioning device. The elongate distal portion of tensioningdevice is inserted into a properly prepared socket in the target boneysurface so that the distal end of the tensioning device, with itssutures is positioned at the bottom of the socket. Tension is thenapplied to the sutures by pulling on their proximal ends, which extendbeyond the proximal portion of the tensioning device, to move the graftinto the desired position, namely into the prepared socket adjacent tothe distal element of the tensioning device. The desired tension may bemaintained by cleating proximal portions of the suture(s) into slotsoptionally formed in the handle of the tensioning device. The anchor (orinterference screw) may then be screwed, threaded or otherwise driveninto the socket, thereby trapping the sutures or graft between theanchor exterior surface and the socket wall. Critically, twisting of thesuture(s) or graft(s) is prevented by means of the non-rotating distaltubular portion of the tensioning device that remains distal to theanchor distal end during anchor placement. In addition, the tension onthe sutures and the position of the graft are maintained duringplacement of the anchor throughout the procedure. After anchorplacement, the driver and tensioning device are withdrawn, removed fromthe site, at which point the sutures may be trimmed to complete theprocedure.

In contrast to the Burkhart and ElAttrache anchor systems, suturetensioning and establishment of the graft position are not accomplishedusing the driver's distal end or using an implant positioned in thedriver's distal end. Rather, suture tension and graft position areestablished and maintained by the distal portion of a non-rotatingtensioning device (“inner assembly”) that extends beyond the driver(“outer assembly”) and anchor distal ends. Because of this, thetransmission of torque to the sutures and/or graft by the driver presentin the Burkhart and ElAttrache systems is eliminated, along with itsassociated suture or graft spin.

The system and method of the present invention provide a simplificationover other currently available anchoring methods and hardware in thatfewer steps are required and moreover the anchor has a simple,single-piece construction. The anchor system is scalable and, due to itssimple construction, may be used with anchors smaller than thosepermitted using other currently available systems. The composition andconstruction in the anchor may be readily modified simply by changingthe material from which it is constructed, by increasing or reducing thediameter or length of the anchor, by increasing or decreasing the wallthickness of the anchor, by modifying the profile of the exterior, or byany combination of these means. All such modifications are contemplatedas within the scope of the present invention.

In another aspect, the present invention provides a method for affixinga soft tissue graft to a target boney surface, the method including thesteps of:

-   -   a. providing a placement system having a cannulated,        non-rotating tensioning device (“inner assembly”) and a        cannulated driver (“outer assembly”), wherein the tensioning        device is positioned within the cannulation or “lumen” of the        driver device,    -   b. positioning a cannulated anchor onto the distal        torque-transmitting portion of the driver, over a distally        extending element of the tensioning device,    -   c. producing a suitably configured hole (i.e., “socket”) in a        prepared boney surface at a desired target location using a        drill, tap, punch or equivalent hole-producing device,    -   d. drawing sutures from the graft into the lumen of the        tensioning device,    -   e. inserting the distal end of the tensioning device into the        socket,    -   f. applying tension to the sutures to draw the graft to a        desired position,    -   g. placing the anchor (or interference screw) in the socket,    -   h. withdrawing the placement system,    -   i. trimming the suture tails, and    -   j. optionally repeating steps (c) through (i) as required.

In an alternate embodiment of the present invention, identical in allaspects to the previous embodiment except as subsequently described, thetubular distal portion of the tensioning device is replaced by a rodhaving formed at its distal end a sharpened fork portion. Two (or more)parallel, axially extending tines form the fork, the tines being spacedapart so that sutures may slide freely through the channel(s) formedbetween the tines. An anchor placement system commensurate with such anembodiment is used in the following manner: First, a cannulated threadedimplant is removably mounted to the torque-transmitting distal portionof the driver. Sutures placed in the graft are then positioned in thechannel(s) of the distal fork portion of the tensioning device. Theelongate distal portion of the tensioning device with the suturespositioned within its distal channel is then inserted into a preparedsocket so that the distal end of the tensioning device with its suturesis positioned at the bottom of the socket. Tension is then applied tothe sutures by pulling on their proximal ends to draw the graft into thedesired position. The desired tension and graft position may bemaintained by cleating the suture proximal portions in slots optionallyformed in the handle of the tensioning device. The anchor is thenscrewed, threaded or otherwise axially driven into the socket by thedriver, thereby trapping the sutures or graft between the anchorexterior surface and the socket wall. Twisting of the sutures or thegraft is prevented by the non-rotating distal fork portion of thetensioning device that remains distal to the anchor distal end duringanchor placement. The tension on the sutures and the position of thegraft are maintained during placement of the anchor. After anchorplacement, the driver and tensioning device are removed from the siteand the sutures trimmed to complete the procedure.

In certain embodiments that are particularly applicable to smalldiameter implants, the tensioning device may be cannulated and coupledwith an elongate element formed from a suitable shape memory metaland/or superelastic polymeric material that, in a first configuration,is provided with a suture retention loop at its distal end. The distalend of the elongate element extends out of and distally away from thedistal end of the cannulated tensioning device so as to be accessible tofree suture ends. In operation, one or more sutures are loaded into thedistal retention loop. The sutures are then tensioned and secured aspreviously described, through cooperation of the cannulated tensioningdevice, cannulated anchoring implant and torque-transmitting driverdevice. After the implant is properly placed, the elongate element maybe readily transformed into a second relatively linear configuration andaxially withdrawn from the tensioning lumen. As noted elsewhere, theelongate element may preferably take the form of a nitinol wire.

An implant placement system of the present embodiment may also include amechanism for releasably preventing relative axial and rotationalmovement between the driver (“outer assembly”) and the tensioning device(“inner assembly”), such means optionally positioned within thecannulation (or “lumen”) of the driver. In a first condition, usedduring tensioning of the suture, relative axial and rotational motion isof the driver relative to the tensioning device is prevented. In asecond condition, used during placement of the anchor, the driver may beadvanced axially on the tensioning device to bring the anchor to thesocket, and rotated to screw the anchor into the socket, with thetensioning device remaining stationery so as to maintain suture tensionand prevent twisting of the sutures.

In a particularly preferred embodiment, prevention of relative motion isprovided by a removable key having one or more protrusions, coupled withfeatures formed on the handles of the tensioning device and driver suchthat, when the features are in alignment, engagement by the one or moreprotrusions of the key prevents relative axial or rotational movementbetween the torque-transmitting driver and the tensioning device.Removal of the key allows the driver to be advanced distally and rotatedrelative to the tensioning device. Other embodiments are anticipated inwhich other means are used to releasably prevent relative motion.

Certain preferred embodiments of the present invention are configuredfor one-handed operation by the surgeon. In these embodiments, asuitable tensioning device is an inner assembly that is irremovably(i.e., permanently) affixed to and/or positioned within an associateddriver device (“outer assembly”), wherein the driver is axially movablebetween a first proximal position and a second distal position relativeto the tensioning device. In the first proximal position, the distalportion of the tensioning device extends distally beyond the implant soas to allow tensioning of sutures and positioning of a graft asdescribed previously herein as well as in related co-pendingapplications incorporated herein by reference. Advancing the driverdistally toward its second, distal position brings the implant to theprepared socket in preparation for placement. Thereafter, the implant isthreaded or axially driven into the socket. Distal motion by the driverdevice (“outer assembly”) relative to the tensioning device (“innerassembly”) may be resisted by a spring within the driver handle or,alternatively, by other motion resistive means such as, for instance, afriction producing element. However produced, the resistance to distalmotion is sufficient to ensure that the distal end of the tensioningdevice remains in contact with the bottom of the socket to maintaingraft position and to prevent rotation of the tensioning device duringanchor placement.

In yet another aspect, like the previous in all other respects except assubsequently described, the suture attached to the graft is positionedwithin the distal fork and tensioned such that a first end of the graftis adjacent to the fork, with the tension optionally being maintained bycleating of the sutures on the tensioning device handle. The distalportion of the tensioning device with the graft is inserted into theprepared socket. The anchor is then threaded or driven into the socketas previously described, thereby directly trapping a portion of thegraft that is adjacent to the first end of the graft between the anchorexterior surface and a first portion of the socket wall, with theattached sutures disposed between the anchor exterior surface and asecond, laterally opposed portion of the socket wall.

In a variation of the previous aspect, the graft may be pierced by thesharpened, distally extending “tines” of the distal fork. The distalportion of the tensioning element with the graft is inserted into theprepared socket. Once again, the anchor is then threaded or driven intothe socket, thereby directly trapping a proximal portion of the graftbetween the anchor exterior surface and a portion of the socket wall.

In another variation of the previous aspect, the graft is pierced by thesharpened distally extending “tines” of the distal fork a predetermineddistance from the graft distal end such that, when the distal portion ofthe tensioning element with the graft is inserted into the preparedsocket, the proximal end of the graft protrudes above the opening of thesocket. The anchor is then threaded or driven into the socket so as toonce again directly trap the graft proximal portion between the anchorexterior surface and first and second laterally opposed portions of thesocket wall.

In another variation of the previous two aspects, the distal fork isreplaced by a single, sharpened, protruding portion configured forpenetration of a graft. Optionally, a “washer” formed of a suitablematerial is removably mounted on the sharpened protruding portion tolimit the depth of penetration of the sharpened portion into the graft.When the anchor is placed, this depth-limiting washer remains in thesocket positioned distal to the anchor, between the anchor and thegraft.

In another variation of the present invention, the distal fork isconfigured not for tissue penetration, but rather for the retention ofsutures placed therein during tensioning, with the distally extendingportions forming a suture-retaining, split loop that defines a distalgap that allows for the placement of sutures therein and their exitafter anchor placement. In certain preferred embodiments the distallyextending portions are formed of a resilient polymeric material or areformed of elastically deformable wires, such that the portions may beinwardly deflected during withdrawal of the placement system afteranchor placement.

In still yet another aspect, identical in form to the devices andinsertion systems previously herein described, the tensioning device hasa proximal handle portion that is an assembly of first and second rigidelements with an elastic element positioned therebetween. Applying adistal force to a first rigid element of the handle of the tensioningdevice causes deflection of the elastic element proportional to thetension in the graft attached to the distal fork. This allows thepractitioner to measure the tension in the graft. By establishing thetension in the graft to a predetermined value prior to placement of theanchor, the tension may then be maintained at the predetermined valueduring anchor placement.

In sum, any graft fixation system that couples a non-rotating innermember (herein referred to interchangeably as “tensioning device” and“inner assembly”) with a movable outer member (herein referred tointerchangeably as “driver”, “driver device”, and “outer assembly”) totension sutures in a prepared socket for the placement of a simple,one-piece cannulated anchor is considered to fall within the scope ofthe present invention.

The unique ability of the systems of the present invention to establishtension in a suture prior to lateral anchor placement, and their abilityto allow an implant to be removed and reinserted by the surgeon ifmodification of the tension is necessary, enable simplified methods formulti-anchor reattachment of soft tissue grafts to bone. Unlike priorart methods that utilize two-piece anchor systems (e.g., a sutureretaining eyelet and a proximal interference screw or plug as inBurkhart, or an anchor and a suture securing “anchor top” as describedby Green et al.), tensioning is accomplished prior to the placement ofany implant. In addition, unlike prior art methods, the suture may beremovably affixed by the lateral implant, with a lateral portion of thesuture being trapped between at least a first portion of the implantouter surface and the wall of the socket in which it is placed. Thisstands in stark contrast to procedures and protocols outlined in theprior art, including the method of Green et al., wherein in the sutureis fixedly secured to the second (lateral) anchor. Thus, the system andmethod of the present invention serves to reduce the number of stepsthat the surgeon must perform, thereby resulting in time and costsavings, and a reduction in the opportunity for error. To wit, if anerror occurs, methods and devices of the present invention permit theeasy removal of the single-piece implant for retensioning of the sutureand reinsertion of the implant, or the relocation of the same implant ifthe original location is determined to be unsuitable.

Accordingly, in a preferred aspect, the present invention provides amethod for affixing a soft tissue graft to a target boney surface, themethod including the steps of:

a. affixing at least one suture to the bone medial to the lateral edgeof the soft tissue by means of a first implant, such as cannulatedknotless suture anchor, such that no portion of the implant lies lateralto the soft tissue edge;

b. passing a first length of suture from the first implant over the softtissue;

c. forming a socket lateral to the edge of the soft tissue such that itis not underneath the soft tissue;

d. establishing a desired tension in the first length of suture; and

e. placing a second implant in the socket so as to trap a portion of thefirst length of suture between at least a first portion of the implantand the wall of the socket so as to provide fixation.

In certain preferred embodiments, the lateral (second) implant may bethreaded so as to provide removable fixation to the suture. In suchembodiments with removable fixation of the suture, the method of thepresent invention may also optionally include the following additionalsteps:

f. removing the lateral implant from the socket in which it was placed;

g. adjusting the tension in the first length of suture; and

h. placing the same implant in the socket so as to trap a portion of thefirst length of suture between at least a first portion of the implantand the wall of the socket so as to provide removable fixation.

Alternatively, in another preferred embodiment, the following optionalsteps may be included:

f. removing the lateral implant from the socket in which it was placed;

g. forming a socket in a new location lateral to the edge of the softtissue such that it is not underneath the soft tissue;

h. establishing a desired tension in the first length of suture; and

i. placing the same implant in the socket so as to trap a portion of thefirst length of suture between at least a first portion of the implantand the wall of the socket so as to provide removable fixation.

Double row repairs of large rotator cuff tears may require constructs inwhich a matrix of medial and lateral implants are used. Sutures may spanthe tissue between a row of medial implants and a row of lateralimplants so as to ensure reliable contact between the soft tissue andunderlying bone in the region between the rows of implants. For example,an implant in the medial row may anchor multiple sutures that extend tomultiple lateral implants as well as to adjacent medial row implants. Inmethods of the current invention, each tissue-spanning suture extendingfrom a first medial anchor may be individually tensioned prior to beingremovably affixed to the bone by a second implant. If the tension in anysuture of the construct is found to be unsuitable, the tension may beadjusted using methods previously herein described. Likewise, if thelocation of any anchor of a construct is found to be unsuitable, theimplant may be relocated using methods previously herein described.Alternatively or additionally, if upon completion of forming a doublerow construct, the surgeon finds that a region of the rotator cuff isnot securely compressed against the underlying bone (a conditionreferred to by surgeons as a “dog ear”) one or more additional implantsmay be placed so as to span the region with tensioned sutures. Suturesfrom the supplemental implant(s) may be integrated into the previouslyformed construct by removing one or more implants of the construct,adding the spanning sutures from the supplemental implants, andtensioning and securing the sutures as previously herein described.

These and other aspects are accomplished in the invention hereindescribed, directed to a system and method for producing one or aplurality of implants for the anchoring of a graft to bone. Furtherobjects and features of the invention will become more fully apparentwhen the following detailed description is read in conjunction with theaccompanying figures and examples. To that end, it is to be understoodthat both the foregoing summary of the invention and the followingdetailed description are of a preferred embodiment, and not restrictiveof the invention or other alternate embodiments of the invention. Inparticular, while the invention is described herein with reference to anumber of specific embodiments, it will be appreciated that thedescription is illustrative of the invention and is not constructed aslimiting of the invention.

BRIEF DESCRIPTION OF THE FIGURES

Various aspects and applications of the present invention will becomeapparent to the skilled artisan upon consideration of the briefdescription of figures and the detailed description of the presentinvention and its preferred embodiments that follows:

FIG. 1A is a plan view of a cannulated driver and anchor illustrative ofan implant placement system of the present invention.

FIG. 1B is an expanded view of the distal portion of the objects of FIG.1A at location C.

FIG. 1C is a side elevational sectional view of the objects of FIG. 1Aat location A-A of FIG. 1A.

FIG. 2A is a perspective view of the objects of FIG. 1A.

FIG. 2B is an expanded view of the distal portion of the objects of FIG.2A at location B.

FIG. 3 is a plan view of a tensioning device illustrative of an implantplacement system of the present invention.

FIG. 4 is an expanded sectional view of the tensioning device of FIG. 3at location A-A.

FIG. 5 is an expanded view of the proximal hub portion of the tensioningdevice of FIG. 3 at location A.

FIG. 6 is a side elevational view of the objects of FIG. 3 .

FIG. 7 is an expanded view of the objects of FIG. 6 at location B.

FIG. 8 is a perspective view of the tensioning device of FIG. 3 .

FIG. 9 is an expanded view of the objects of FIG. 8 at location C.

FIG. 10 is a side elevational view of an illustrative key for use inconnection with an implant placement system of the present invention.

FIG. 11 is a perspective view of the objects of FIG. 10 .

FIG. 12 is an exploded view of the assembly of the cannulated driver andanchor of FIG. 1A, the tensioning device of FIG. 3 , and the key of FIG.10 that together form a first embodiment of an implant placement systemof the present invention.

FIG. 13 is a plan view of a fully assembled first embodiment of animplant placement system of the present invention.

FIG. 14 is an expanded view of the distal portion of FIG. 13 at locationA.

FIG. 15 is an expanded side elevational sectional view of the objects ofFIG. 13 at location A-A.

FIG. 16 is a side elevational view of the objects of FIG. 13 .

FIG. 17 is an expanded view of the objects of FIG. 13 at location B.

FIG. 18 is a perspective view of the objects of FIG. 13 .

FIG. 19 is an expanded view of the objects of FIG. 13 at location C.

FIG. 20 is a perspective view of a first embodiment implant placementsystem with sutures being loaded into the system.

FIG. 21 is a perspective view of the first embodiment implant placementsystem with the sutures loaded.

FIG. 22 schematically depicts a socket placed in a bone prior to theplacement of an implant.

FIG. 23 depicts the first embodiment implant placement system positionedfor the first step of implant placement.

FIG. 24 depicts the proximal portion of the first embodiment implantplacement system during the first step of implant placement.

FIG. 25 depicts the distal portion of the first embodiment implantplacement system during the first step of implant placement.

FIG. 26 depicts the first embodiment implant placement system positionedfor the second step of implant placement.

FIG. 27 depicts the proximal portion of the embodiment implant placementsystem during the second step of implant placement.

FIG. 28 depicts the distal portion of the first embodiment implantplacement system during the second step of implant placement.

FIG. 29 depicts the first embodiment implant placement system positionedfor the third step of implant placement.

FIG. 30 depicts the proximal portion of the first embodiment implantplacement system during the second step of implant placement.

FIG. 31 depicts the distal portion of the first embodiment implantplacement system during the third step of implant placement.

FIG. 32 depicts the site at the completion of implant placement using animplant placement system of the present invention.

FIG. 33 is a plan view of a second embodiment of an implant placementsystem of the present invention, wherein the tubular distal portion ofthe tensioning device is replaced by a rod having formed at its distalend a sharpened fork portion.

FIG. 34 is a side elevational view of the objects of FIG. 33 .

FIG. 35 is an expanded proximal end view of the objects of FIG. 33 .

FIG. 36 is an expanded plan view of the distal portion of the elementsof FIG. 33 .

FIG. 37 is a side elevational view of the objects of FIG. 36 .

FIG. 38 is a sectional view of the objects of FIG. 36 at location B-B.

FIG. 39 is a distal perspective view of the objects of FIG. 33 .

FIG. 40 is an expanded view of the objects of FIG. 39 at location A.

FIG. 41 is a proximal perspective view of the objects of FIG. 33 .

FIG. 42 is an expanded view of the objects of FIG. 41 at location B.

FIG. 43 depicts an illustrative method for positioning sutures in asocket for the securing of a graft with an anchor, using the assembly ofFIG. 33 .

FIG. 44 is an expanded view of the distal portion of the objects of FIG.43 that depicts the placement site.

FIG. 45 depicts the alternate “fork” embodiment system of FIG. 33 , withthe sutures tensioned so as to position the graft.

FIG. 46 is an expanded view of the distal portion of the objects of FIG.45 that depicts the placement site.

FIG. 47 is an expanded view of the site depicting the system with theanchor placed.

FIG. 48 is an expanded view of the site at completion of the anchorplacement and removal of the system with the sutures trimmed.

FIG. 49 depicts a first step of an alternate repair method for securinga graft in a socket using an implant placement system as contemplated bythe present invention.

FIG. 50 depicts a second step of the alternate repair method

FIG. 51 depicts a third step of the alternate repair method.

FIG. 52 depicts the site of the graft attachment at the completion ofthe repair using the alternate repair method.

FIG. 53 depicts a first step of a second alternate repair method forsecuring a graft in a socket using an implant placement system ascontemplated by the present invention.

FIG. 54 depicts a second step of the second alternate repair method

FIG. 55 depicts a third step of the second alternate repair method.

FIG. 56 depicts a fourth step of the second alternate repair method.

FIG. 57 depicts the site of the graft attachment at the completion ofthe repair using the second alternate embodiment repair method.

FIG. 58 depicts a first step of a third alternate repair method forsecuring a graft in a socket using an implant placement system ascontemplated by the present invention.

FIG. 59 depicts a second step of the third alternate repair method

FIG. 60 depicts a third step of the third alternate repair method.

FIG. 61 depicts a fourth step of the third alternate repair method.

FIG. 62 depicts a fifth step of the third alternate repair method.

FIG. 63 depicts the site of the graft attachment at the completion ofthe repair using the third alternate embodiment repair method.

FIG. 64 is a plan view of a distal assembly for the tensioning device inan alternate embodiment of an implant placement system contemplated bythe present invention, one that includes a force-indicating innertensioning assembly.

FIG. 65 is a side elevational view of the objects of FIG. 64 .

FIG. 66 is a sectional view of the objects of FIG. 64 at location A-A.

FIG. 67 is an expanded proximal axial view of the objects of FIG. 64 .

FIG. 68 is a perspective view of the objects of FIG. 64 .

FIG. 69 is an expanded view of the proximal portion of the objects ofFIG. 68 at location A.

FIG. 70 is a plan view of a handle portion of the tensioning device inan alternate embodiment of an implant placement system contemplated bythe present invention.

FIG. 71 is a side elevational view of the objects of FIG. 70 .

FIG. 72 is a sectional view of the objects of FIG. 70 at location A-A.

FIG. 73 is a perspective view of the objects of FIG. 70 .

FIG. 74 is an expanded proximal axial view of the objects of FIG. 70 .

FIG. 75 is a perspective view of an end cap configured for use with thetensioning device in the alternate embodiment of an implant placementsystem depicted in FIG. 70 .

FIG. 76 is a plan view of the objects of FIG. 75 .

FIG. 77 is a distal axial view of the objects of FIG. 75 .

FIG. 78 is a side elevational view of the objects of FIG. 75 .

FIG. 79 is a sectional view of the objects of FIG. 76 at location A-A.

FIG. 80 is a plan view of the assembly of the tensioning device of FIG.64 , the handle portion of FIG. 70 , and the cap of FIG. 75 thattogether form an alternate embodiment of an implant placement system ofthe present invention that allows the surgeon to measure the tension inthe graft during the attachment of the graft in accordance with themethods of the present invention.

FIG. 81 is an expanded view of the proximal portion of the objects ofFIG. 80 at location A.

FIG. 82 is a perspective view of the objects of FIG. 80 .

FIG. 83 is an expanded view of the proximal portion of the objects ofFIG. 82 at location A.

FIG. 84 is a central expanded side elevational sectional view of theobjects of FIG. 81 .

FIG. 85 is a perspective view of an outer driver assembly in analternate embodiment of an implant placement system in accordance withthe present invention.

FIG. 86 is a plan view of the driver of FIG. 85 .

FIG. 87 is a side elevational view of the driver of FIG. 85 .

FIG. 88 is a sectional view of the objects of FIG. 86 at location A-A.

FIG. 89 is a perspective view of an inner tensioning assembly for analternate embodiment of an implant placement system of the presentinvention.

FIG. 90 is a plan view of the objects of FIG. 89 .

FIG. 91A is an expanded sectional view of the objects of FIG. 89 atlocation A-A.

FIG. 91B is an expanded view of the objects of FIG. 91A at location A.

FIG. 92 is a perspective view of a control element for an alternateembodiment of an implant placement system of the present invention.

FIG. 93 is a side elevational view of the control element of FIG. 92 .

FIG. 94 is a perspective view of an exploded assembly of the outerdriver assembly of FIG. 85 , the inner tensioning assembly of FIG. 89and the control element of FIG. 92 that together form an alternateembodiment of an implant placement system in accordance with the presentinvention.

FIG. 95 is a perspective view of an alternate embodiment of an implantplacement system in accordance with the present invention that is formedof the assembled elements of FIG. 94 , with the distal portion of theinner tensioning assembly protruding beyond the implant in preparationfor implant placement.

FIG. 96 is a plan view of the objects of FIG. 95 .

FIG. 97 is a side elevational view of the elements of FIG. 95 .

FIG. 98A is an expanded sectional view of the objects of FIG. 96 atlocation A-A.

FIG. 98B is an expanded view of the objects of FIG. 98A at location A.

FIG. 98C is an expanded view of the objects of FIG. 98B at location C.

FIG. 99 is an expanded sectional view of the objects of FIG. 96 atlocation D-D.

FIG. 100 is a perspective view of the implant placement system of FIG.95 with the outer driver assembly and implant advanced distally as whenthe implant is fully placed in a socket.

FIG. 101 is a plan view of the objects of FIG. 100 .

FIG. 102 is a side elevational view of the objects of FIG. 100 .

FIG. 103 is an expanded sectional view of the objects of FIG. 101 atlocation A-A.

FIG. 104 is an expanded sectional view of the objects of FIG. 101 atlocation D-D.

FIG. 105 is a perspective view of the exploded assembly of an alternateembodiment of an implant placement system in accordance with the presentinvention.

FIG. 106A is a perspective view of an alternate embodiment of an implantplacement system of the present invention that is formed of the elementsand assemblies of FIG. 105 , with the distal portion of the innertensioning assembly extended beyond the implant in preparation forimplant placement.

FIG. 106B is an expanded view of the objects of FIG. 106A at location A.

FIG. 107 is a plan view of the implant placement system of FIG. 106 .

FIG. 108 is a side elevational view of the objects of FIG. 106 .

FIG. 109 is an expanded sectional view of the objects of FIG. 107 atlocation B-B.

FIG. 110 is an expanded sectional view of the objects of FIG. 107 atlocation A-A.

FIG. 111 is a perspective view of the implant placement system of FIG.106 , with the outer driver assembly and implant advanced on the innertensioning assembly, as when an implant is fully placed in a socket.

FIG. 112 is a plan view of the objects of FIG. 111 .

FIG. 113 is a side elevational view of the objects of FIG. 111 .

FIG. 114 is an expanded sectional view of the objects of FIG. 112 atlocation B-B.

FIG. 115 is an expanded sectional view of the objects of FIG. 112 atlocation A-A.

FIG. 116 is a perspective view of the exploded assembly of an alternateembodiment implant placement system of the present invention.

FIG. 117 is a perspective view of an alternate embodiment of an implantplacement system of the present invention, one formed from the elementsand assemblies of FIG. 116 with the distal portion of the innertensioning assembly protruding beyond the implant in preparation forimplant placement.

FIG. 118 is a plan view of the objects of FIG. 117 .

FIG. 119 is a side elevational view of the objects of FIG. 117 .

FIG. 120 is an expanded sectional view of the objects of FIG. 118 atlocation B-B.

FIG. 121 is an expanded sectional view of the objects of FIG. 118 atlocation A-A.

FIG. 122 is a perspective view of the implant placement system of FIG.117 with the outer driver assembly and implant advanced on the innertensioning assembly as when an implant is fully place in a socket.

FIG. 123 is a plan view of the objects of FIG. 122 .

FIG. 124 is a side elevational view of the objects of FIG. 122 .

FIG. 125 is an expanded sectional view of the objects of FIG. 123 atlocation A-A.

FIG. 126 is an expanded sectional view of the objects of FIG. 123 atlocation B-B.

FIG. 127 is a perspective view of an inner tensioning assembly suitablefor use in an alternate embodiment of an implant placement system of thepresent invention.

FIG. 128 is a plan view of the objects of FIG. 127 .

FIG. 129 is an expanded sectional view of the objects of FIG. 128 atlocation A-A.

FIG. 130 is a plan view of an alternate embodiment of an implantplacement system of the present invention that incorporates the innertensioning assembly of FIG. 127 and with the outer driver assembly inits proximal position.

FIG. 131 is an expanded sectional view of the objects of FIG. 130 atlocation A-A.

FIG. 132 is a plan view of the implant placement system of FIG. 130 withthe outer driver assembly in its distal position.

FIG. 133 is an expanded sectional view of the objects of FIG. 132 atlocation A-A.

FIG. 134 is a perspective view of the inner assembly for an alternateembodiment of an implant placement system in accordance with the presentinvention.

FIG. 135 is an expanded view of the objects of FIG. 134 at location A.

FIG. 136 is a plan view of the objects of FIG. 134 .

FIG. 137 is an expanded sectional view of the objects of FIG. 136 atlocation A-A.

FIG. 138 is a plan view of an alternate embodiment of an implantplacement system of the present invention that incorporates the innerassembly of FIG. 134 .

FIG. 139 is an expanded sectional view of the objects of FIG. 138 atlocation A-A.

FIG. 140 is a perspective view of the distal portion of an alternateembodiment of an implant placement system in accordance with the presentinvention.

FIG. 141 is a plan view of the objects of FIG. 140 .

FIG. 142 is a sectional view of the objects of FIG. 140 at location A-A.

FIG. 143 is an expanded plan view of a modified distal end of atensioning device for use in an alternate embodiment of an implantplacement system in accordance with the present invention.

FIG. 144 is a distal perspective view of the objects of FIG. 143 .

FIG. 145 is a proximal perspective view of the objects of FIG. 143 .

FIG. 146 is an expanded plan view of the distal end of an alternateembodiment of an implant placement system of the present invention.

FIG. 147 is a perspective view of the objects of FIG. 146 .

FIG. 148 is an expanded perspective view of the objects of FIG. 146 .

FIG. 149 is a perspective view of a penetration-limiting element for usein an alternate embodiment of an implant placement system of the presentembodiment.

FIG. 150 is a side elevational view of the objects of FIG. 149 .

FIG. 151 is an expanded plan view of an alternate embodiment of animplant placement system of the present invention incorporating thepenetration-limiting element of FIG. 149 .

FIG. 152 is an expanded view of the objects of FIG. 151 at location D.

FIG. 153 is a perspective view of the objects of FIG. 151 .

FIG. 154 is an expanded view of the objects of FIG. 153 at location C.

FIG. 155 is a perspective view of the distal portion of an alternateembodiment of an implant placement system of the present invention thatdepicts a penetration or depth-limiting element positioned for mountingto the distal end of a distal element.

FIG. 156 is a perspective view of the elements of FIG. 155 assembled inpreparation for use.

FIG. 157 depicts a first step in a procedure for reattachment of atendon to a boney surface using the components depicted in FIGS. 155 and156 .

FIG. 158 depicts a second step in the procedure of FIG. 157 .

FIG. 159 depicts a third step in the procedure of FIG. 157 .

FIG. 160 depicts a fourth step in the procedure of FIG. 157 .

FIG. 161 depicts the surgical site at the completion of reattachment ofa graft to a boney surface using the procedure the beginning of which isdepicted in FIG. 157 .

FIG. 162 depicts a first step in an alternate procedure for reattachmentof a tendon to a boney surface using the components depicted in FIGS.155 and 156 .

FIG. 163 depicts a second step in the procedure of FIG. 162 .

FIG. 164 depicts a third step in the procedure of FIG. 162 .

FIG. 165 depicts a fourth step in the procedure of FIG. 162 .

FIG. 166 depicts a fifth step in the procedure of FIG. 162 .

FIG. 167 depicts the surgical site at the completion of the procedure ofFIG. 162 .

FIG. 168 is an expanded plan view of the distal end of an alternateembodiment of an implant placement system of the present invention thatincludes a resilient distal element.

FIG. 169 is an expanded view of the objects of FIG. 168 at location B.

FIG. 170 is a perspective view of the resilient distal element of FIG.168 .

FIG. 171 is a plan view of the resilient distal element of FIG. 169 .

FIG. 172 is a perspective view of a placed first medial implant of adouble row construct for rotator cuff reattachment according to themethods of the present invention.

FIG. 173 is a perspective view of the first and second medial implantsof a double row fixation with a tensioned suture joining the implants.

FIG. 174 is a perspective view of the medial implants of FIG. 173 and afirst lateral implant placed with tensioned sutures joining the medialimplants to the first lateral implant.

FIG. 175 is a perspective view of the elements of FIG. 174 with a secondlateral implant placed and joined to the medial implants by tensionedsutures.

FIG. 176 is a perspective depiction of a completed double row repairusing the elements of FIG. 175 .

FIG. 177 is a perspective view of a double row construct of the presentinvention in which a lateral implant has been removed in preparation forrepositioning the implant.

FIG. 178 is a perspective view of the elements of FIG. 177 with theaddition of a socket formed in a new location.

FIG. 179 is a perspective view of the elements of FIG. 178 wherein thelateral implant is placed in the socket formed in the new location andtensioned sutures connect to the medial implants.

FIG. 180 is a perspective view of the modified double row construct ofFIGS. 177 and 178 .

FIG. 181 depicts a double row construct of the present invention havinga region adjacent to the construct in which a lateral region of the softtissue is not in contact with the underlying bone.

FIG. 182 depicts the objects of FIG. 181 wherein a lateral implantadjacent to the lateral region of non-contacting soft tissue is removedand a small diameter socket has been formed in proximity to thenon-contacting tissue region, lateral to the edge of the soft tissue.

FIG. 183 depicts the objects of FIG. 182 wherein the lateral anchorwhich was removed is again placed in its original socket and a smallanchor of the implant system of FIG. 80 is placed in the adjoining smalldiameter socket, with tensioned sutures spanning the soft tissue.

FIG. 184 depicts the completed construct of FIG. 183 .

FIG. 185 depicts another repair construct in which a region ofnon-contacting soft tissue adjacent to the original double row constructis pressed against the underlying bone by sutures tensioned betweensmall diameter anchors placed adjacent to the original construct.

FIG. 186 depicts a two-implant repair in which the lateral anchor is asmall push-in plug-type implant, the construct being formed usingmethods of the present invention.

FIG. 187 depicts a double-row repair construct in which the lateralanchors are small push-in plug-type implants, the construct being formedusing methods of the present invention.

FIG. 188 depicts a repair construct with two medial implants and asingle lateral implant wherein the anchors are small push-in implants,the construct being formed using methods of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Aspects of the present invention relate to, coordinate with, and/oroverlap with aspects described by the present inventors in theirprevious patent filings. For example, aspects of the present inventionare compatible with and thus may be combined with the ceramic implantplacement systems and superelastic suture retention loops described inU.S. Pat. No. 9,770,240 issued Sep. 26, 2017. Likewise, aspects of thepresent invention are suitable for use in the context of the multipleimplant construction and fixation methods described in U.S. Pat. No.9,717,587 issued Aug. 1, 2017 and U.S. Pat. No. 9,999,496 issued Jul.19, 2018. The present invention is further compatible with and thus mayinclude the split loop constructions described in U.S. Pat. No.9,907,548 issued Mar. 6, 2018. As such, these preceding disclosures arehereby incorporated by reference herein in their entirety.

To that end, U.S. Pat. Nos. 9,717,587 and 9,999,496 describe double rowconstruction methods for securing soft tissue to an underlying boneysurface and present illustrative examples of such in FIGS. 41-50, 53-56,and 59-61 (presented herein as FIGS. 172-188 ). Namely, FIGS. 172-188depict exemplary methods for constructing a double row repair, formodifying the tension in one or more sutures within a double rowconstruct, for repositioning an implant within a double row construct,and for adding one or more additional implants to a previously formeddouble row construct. In particular:

FIG. 172 depicts a first medial implant 3630 with sutures 300, the firststep in forming a double row construct for the purpose of securing softtissue 100 to boney surface 200. In FIG. 173 , second medial implant3632 is placed and suture 332 is tensioned during placement of implant3632 as previously herein described. If, following placement of implant3632 the tension in suture 332 is found to be suboptimal, implant 3632may be backed out and the suture re-tensioned as previously hereindescribed. Referring now to FIG. 174 , subsequently, first lateralimplant 1630 is placed previously herein described and depicted. Sutures334 and 336 are tensioned as previously herein described. If the tensionin either suture is found to be suboptimal, implant 1630 may be backedout and the tension in each suture leg adjusted as previously hereindescribed. Second medial anchor 1632 is then placed as depicted andsutures 338 and 340 tensioned, the tension being subsequently adjustedif required as previously described. With the double row construct nowcompleted, the surgeon may examine the tension of each suture in theconstruct, and if any suture is determined to have suboptimal tension,to adjust the tension in that suture by backing out the appropriateimplant, adjusting the suture tension and then reseating the implant.FIG. 176 depicts the double row construct with the sutures trimmed tocomplete the repair.

Referring again to FIG. 175 , if the surgeon determines that theconstruct is suboptimal and that the repair may be improved byrepositioning of an implant, a socket may be formed in the desiredimplant location. Thereafter the implant to be repositioned is removedfrom its original socket and placed in the newly formed socket usingmethods previously herein described. In FIG. 177 , second lateralimplant 1632 has been removed from socket 204 in which it was previouslyplaced. In FIG. 178 socket 206 has been formed in the alternatelocation, and in FIG. 179 implant 1632 has been placed in newly formedsocket 206 and sutures 338 and 340 tensioned and affixed thereby. FIG.180 depicts the completed repair with the suture tails trimmed.

FIG. 181 depicts the construct of FIG. 175 wherein a region 110 of thelateral portion of soft tissue 100 adjacent to the previously formedconstruct is not pressed against underlying boney surface 200. If thesoft tissue within the region is not pressed to the boney surface, therepair may not result in complete reattachment of soft tissue 100 toboney surface 200.

FIGS. 182-185 depict an alternate double row construct of the presentinvention with reference to the anchor system 4000. Region 110 whereinsoft tissue 100 is not pressed against underlying boney surface 200 ispositioned adjacent to the construct. Tissue 100 within region 110 maybe pressed to underlying boney surface 200 by supplementing theconstruct of FIG. 181 with implant 4630. As depicted in FIG. 182 ,implant 1632 is removed from socket 204 and socket 206, configured toreceive implant 4630, is formed a short distance from socket 204 andlaterally aligned such that suture between implant 3630 and anchor 4630to be placed in socket 204 spans region 110 of soft tissue 100.Thereafter, as depicted in FIG. 183 , suture 340 is tensioned andaffixed by implant 1632 as previously described. Suture 338 is tensionedand affixed by implant 4630 in the manner previously herein described,suture 338 spanning region 110 so as to press tissue 100 therein againstunderlying boney surface 200. FIG. 184 depicts the completed augmentedconstruct with the sutures trimmed.

FIG. 185 depicts an alternate construct wherein the region 110 ispressed against underlying boney surface 200 through supplementing ofthe original construct depicted in FIG. 181 . In this construct lateralimplant 4630 and a medial implant 4632 are added to the construct suchthat sutures 342 and 344 span region 110 so as to compress tissue 100therein against underlying boney surface 200.

FIG. 186 depicts an alternate double row method in which the threadedanchor 1600 is replaced by push-in implant 5600 (see FIGS. 85-104 ).Namely, following placement of medial implant 3600, suture 300 istensioned as previously herein described and secured by implant 5600which is pushed in rather than threaded in like lateral implant 1600.Because lateral implant 5600 is not removable after placement,adjustment of the tension in suture 300 is not possible. Because thetension is established prior to the placement of implant 5600 and is notchanged during the placement of implant 5600, the tension in suture 300in the completed construct is as intended by the surgeon.

FIG. 187 depicts a multi-anchor repair construct formed using methods ofthe present invention wherein lateral anchors 5600 are push-in implantsplaced using system 5000 depicted in FIG. 85-104 . As in the constructdepicted in FIG. 186 , sutures 300 are tensioned prior to placement ofimplants 5600. Implants 5600 are irremovable after placement using theelements of implant system 5000. The use of small diameter push-inimplants 5600 may be necessitated by anatomies in which an effectivemulti-anchor construct requires the use of implants which have a minimalfootprint.

FIG. 188 depicts a multi-anchor construct in which the two medial andsingle lateral anchors are all small-diameter push-in implants 5600,sutures 300 being tensioned according to the principles of the presentinvention as previously described herein.

Although any methods and materials similar or equivalent to thosedescribed herein can be used in the practice or testing of embodimentsof the present invention, the preferred methods, devices, and materialsare now described. However, before the present materials and methods aredescribed, it is to be understood that the present invention is notlimited to the particular sizes, shapes, dimensions, materials,methodologies, protocols, etc. described herein, as these may vary inaccordance with routine experimentation and optimization. It is also tobe understood that the terminology used in the description is for thepurpose of describing the particular versions or embodiments only, andis not intended to limit the scope of the present invention which willbe limited only by the appended claims. Accordingly, unless otherwisedefined, all technical and scientific terms used herein have the samemeaning as commonly understood by one of ordinary skill in the art towhich the present invention belongs. However, in case of conflict, thepresent specification, including definitions below, will control.

In the context of the present invention, the following definitionsapply:

The words “a”, “an” and “the” as used herein mean “at least one” unlessotherwise specifically indicated. Thus, for example, reference to an“opening” is a reference to one or more openings and equivalents thereofknown to those skilled in the art, and so forth.

The term “proximal” as used herein refers to that end or portion whichis situated closest to the user of the device, farthest away from thetarget surgical site. In the context of the present invention, theproximal end of the implant system of the present invention includes thedriver and handle portions.

The term “distal” as used herein refers to that end or portion situatedfarthest away from the user of the device, closest to the targetsurgical site. In the context of the present invention, the distal endof the implant systems of the present invention includes componentsadapted to fit within the pre-formed implant-receiving socket.

In the context of the present invention, the terms “cannula” and“cannulated” are used to generically refer to the family of rigid orflexible, typically elongate, lumened surgical instruments thatfacilitate access across tissue to an internally located surgery site.

The terms “tube” and “tubular” are interchangeably used herein to referto a generally round, long, hollow component having at least one centralopening often referred to as a “lumen”.

The terms “lengthwise” and “axial” are used interchangeably herein torefer to the direction relating to or parallel with the longitudinalaxis of a device. The term “transverse” as used herein refers to thedirection lying or extending across or perpendicular to the longitudinalaxis of a device.

The term “lateral” pertains to the side and as used herein, refers tomotion, movement, or materials that are situated at, proceeding from, ordirected to a side of a device.

The term “medial” pertains to the middle, and as used herein, refers tomotion, movement or materials that are situated in the middle, inparticular situated near the median plane or the midline of the deviceor subset component thereof.

As discussed above, when a tissue, more particularly a soft connectivetissue in a joint space, becomes damaged or torn from its associatedbone or cartilage, surgery is usually required to reattach the tissue orreconstruct the bone. The present invention is directed to various meansand mechanisms for securing the displaced tissue to boney tissue.

As used herein, the term “tissue” refers to biological tissues,generally defined as a collection of interconnected cells that perform asimilar function within an organism. Four basic types of tissue arefound in the bodies of all animals, including the human body and lowermulticellular organisms such as insects, including epithelium,connective tissue, muscle tissue, and nervous tissue. These tissues makeup all the organs, structures and other body contents. While the presentinvention is not restricted to any particular soft tissue, aspects ofthe present invention find particular utility in the repair ofconnective tissues such as ligaments or tendons, particularly those ofthe shoulder, elbow, knee or ankle joint.

In a similar fashion, while the present invention is not restricted toany particular boney tissue, a term used herein to refer to both bonesand cartilage, aspects of the present invention find particular utilityin the repair or reattachment of connective tissues to the boneyelements of the shoulder, elbow, wrist, hand, hip, knee or ankle joint.

When the damaged tissue is of sufficient quantity and quality, thedamaged portion may simply be directly reattached to the bone from whichit was torn so that healing back to the bone can take place. However, inother situations, a “graft” may be needed to stimulate regrowth andpermanent attachment. In the context of the present invention, the term“graft” refers to any biological or artificial tissue being attached tothe boney tissue of interest, including:

-   -   Autografts, i.e., grafts taken from one part of the body of an        individual and transplanted onto another site in the same        individual, e.g., ligament graft;    -   Isografts, i.e., grafts taken from one individual and placed on        another individual of the same genetic constitution, e.g.,        grafts between identical twins;    -   Allografts, i.e., grafts taken from one individual placed on        genetically non-identical member of the same species; and    -   Xenografts, i.e., grafts taken from one individual placed on an        individual belonging to another species, e.g., animal to man.        Autografts and isografts are usually not considered as foreign        and, therefore, do not elicit rejection. Allografts and        xenografts are recognized as foreign by the recipient thus carry        a high risk of rejection. For this reason, autographs and        isografts are most preferred in the context of the present        invention.

Surgical interventions such as contemplated herein generally require theboney tissue to be prepared for receiving the graft. In the context ofthe present invention, such preparation includes the formation of a“socket”, i.e., a hole punched or drilled into the bone into which aprosthetic device such as an implant may be received. The socket may beprepared at the desired target location using conventional instrumentssuch as drills, taps, punches or equivalent hole-producing devices. Inother embodiments the socket may be formed at the time of implantplacement using a sharpened distal portion that is integral with theimplant placement system and that protrudes beyond the distal end of theimplant.

While certain procedures contemplate directly attaching the graft to thebone, the more common route involves the employment of an implantspecially configured to hold and/or enable attachment of the graft tothe boney tissue. As used herein, the term “implant” refer to aprosthetic device fabricated from a biocompatible and/or inert material.In the context of the present invention, examples of such “implants”include conventional and knotless anchors of both the screw-threaded andinterference-fit variety, as well as interference screws.

In certain embodiments, the present invention contemplates fabricationof the implant from either a metallic material or a suitable polymericmaterial, including, but not limited to, polyetheretherketone (PEEK), apolymeric composite such as, for instance, carbon fiber reinforced PEEK(PEEK CF), or of a suitable bioabsorbable material such as, forinstance, polylactic acid (PLA). The present invention also contemplatesthe use of very small knotless anchors produced from ceramic materialsusing a process known as “Ceramic Injection Molding” or simply “CIM”.The tensile strength of PEEK material is typically between 10,000 and15,000 psi. In comparison, the tensile strength of alumina is generallyin excess of 200,000 psi. Furthermore, recently developed materials suchas Zirconia Toughened Alumina (ZTA) by Coorstek Inc. (Golden, Colo.)have a high degree of toughness in addition to high tensile strength.These materials, being ceramic, do not have a yield point and thereforedo not deform under load. The high tensile strength and the absence ofyielding under load of an implant constructed of such ceramic materialsallow torque to be transmitted to the implant through features that arenot producible by the machining of metal or that would fail in use ifformed from a polymeric material such as PEEK.

In certain embodiments, the implant may take the form of a ceramicinterference plug, wherein the high elastic modulus and high strength ofthe ceramic materials is beneficial for small and miniature interferencetype anchors that are driven axially into a prepared socket. The highmodulus and high strength of the materials allows the thickness of thewall between the central lumen and the outer surface to be reducedcompared to interference type anchors produced from polymeric materialswithout reducing the compressive force which retains the one or moresutures between the outer wall of the implant and the wall of thesocket.

A preferred implant system of the present invention is comprised of anoptionally cannulated tensioning device (also referred to as the“inserter” or “insertion device”) slidably received within the lumen ofa cannulated driver device (also referred to as the implant driver orsimply “driver”) that together serve to tension sutures in a preparedsocket for the placement of a simple, one-piece, cannulated anchor. Inthe Examples below, the present invention makes reference to variouslock-and-key type mating mechanisms that serve to establish and securethe axial and rotational arrangement of these device components.However, it will again be readily understood by the skilled artisan thatthe position of the respective coordinating elements (e.g., recessedslots and grooves that mate with assorted projecting protrusions,protuberances, tabs and splines) may be exchanged and/or reversed asneeded.

In the context of the present invention, a preferred implant placementsystem of the present invention includes an optionally cannulatedtensioning assembly (also referred to as the “inserter” or “insertionassembly”) slidably received within the lumen of a cannulated driverdevice (also referred to as the “driver”) that together serve to tensionsutures in a prepared socket for the placement of a simple one-piececannulated anchor. The implant placement system of the present inventionrequires a robust connection between the “driver device” and theassociated “implant” or “anchor” so as to ensure that the two rotate asa single unit such that rotational force or “torque” applied to theproximal end of the system (e.g., via the proximal handle portion of thedriver device) is transmitted to the distal end of the system (e.g., thedistal end of the implant disposed in the prepared socket) withoutincident or interruption. This continuous “torque transfer” along thelength of the system, from proximal to distal end, is critical to thefunction of the driver, enabling it to distally advance the implant andfirmly secure the implant (and any associated sutures or tissues) in thebiological site of interest. In the context of the present invention,this continuous torque transfer is achieved by means of coordinating“torque-transmitting” elements, namely a distal “torque-transmittingportion” of the driver device that is configured to mate with and/orconform to a “torque-transmitting” (or alternatively “torque-receiving”or “torque-transferring”) portion of the implant, such “portion”including at a minimum the proximal end of the implant though thepresent invention contemplates embodiments where “torque-transmitting”features on the implant extend along the length of the implant. Therespective “torque-transmitting” features on the driver device andimplant cooperate to ensure that any proximal torque applied by the userto the proximal handle portion of the device is directly conveyed(“transmitted”) to the distal end of the implant.

In certain embodiments, the torque-transmitting portion of the implantmay take the form of a laterally extending slot in the proximal end ofthe implant similar to a standard screwdriver slot; however, othergeometries are contemplated and described in detail herein as well as indisclosures incorporated by reference herein. In addition, like theimplant itself, the distal torque-transmitting portion of the driver mayalso be fabricated from a ceramic material and formed by ceramicinjection molding so as to allow miniaturization of thetorque-transmitting features.

The present invention makes reference to insertion devices commonlyreferred to in the art as “drills” and “drivers”, i.e., devices that“drill” the socket and “drive” the implant into the socket. In thecontext of the present invention, the drills and drivers may beconventional, e.g., rigidly linear as previously herein described, or,as discussed in detail herein, “off-axis”, e.g., having an angularlyoffset distal portion adapted to drill off-axis sockets in boney tissuesthat are remote and difficult to access and drive therein thecorresponding implant, such as an anchor or interference screw.

In certain embodiments, the present invention contemplates securing thegraft to the implant via sutures. In the context of the presentinvention, the term “suture” refers to a thread-like strand or fiberused to hold body tissues after surgery. Sutures of different shapes,sizes, and thread materials are known in the art and the presentinvention is not restricted to any particular suture type. Accordingly,in the context of the present invention, the suture may be natural orsynthetic, monofilament or multifilament, braided or woven, permanent orresorbable, without departing from the spirit of the invention.

In certain embodiments, the present invention makes reference to anelongate element of a superelastic and/or shape memory materialconfigured to include a suture retention loop at its distal end anddesigned to be slidably received within a lumen of a cannulatedtensioning device or inserter. In certain preferred examples, theelongate element takes the form of a “nitinol wire”. In the context ofthe present invention, “nitinol” is a super elastic metal alloy ofnickel and titanium. In a preferred embodiment, the two elements arepresent in roughly equal atomic percentage (e.g., Nitinol 55, Nitinol60). Nitinol alloys exhibit two closely related and unique properties:shape memory effect (SME) and superelasticity (SE; also calledpseudoelasticity, PE). Shape memory is the ability of nitinol to undergodeformation at one temperature, then recover its original, undeformedshape upon heating above its “transformation temperature”.Superelasticity occurs at a narrow temperature range just above itstransformation temperature; in this case, no heating is necessary tocause the undeformed shape to recover, and the material exhibitsenormous elasticity, some 10-30 times that of ordinary metal.

The present invention also makes reference to high strength polymericmaterials and high tensile strength ceramic materials, such as aluminaor zirconia, that may be formed to complex shapes by a process referredto as Ceramic Injection Molding (CIM). In this process, ceramic powderand a binder material are molded to a shape that is subsequently firedin a furnace to eliminate the binder material and sinter the ceramicpowder. During this sintering operation the item is reduced in size bytwenty to thirty percent and achieves near 100% density with very highdimensional repeatability. Ceramic materials that are routinely moldedand thus contemplated by the present invention include, but are notlimited to, alumina, zirconia toughened alumina (ZTA) partiallystabilized zirconia (PSZ) and silicon nitride (Si3N4). The flexularstrengths of these materials range from 55,000 psi to 250,000 psi, farhigher than the 25,000 psi flexular strength of implantable PEEKmaterial.

The present invention has both human medical and veterinaryapplications. Accordingly, the terms “subject” and “patient” are usedinterchangeably herein to refer to the person or animal being treated orexamined. Exemplary animals include house pets, farm animals, and zooanimals. In a preferred embodiment, the subject is a mammal, morepreferably a human.

Hereinafter, the present invention is described in more detail byreference to the Figures and Examples. However, the following materials,methods, figures, and examples only illustrate aspects of the inventionand are in no way intended to limit the scope of the present invention.For example, while the present invention makes specific reference toarthroscopic procedures, it is readily apparent that the teachings ofthe present invention may be applied to other minimally invasiveprocedures and are not limited to arthroscopic uses alone. As such,methods and materials similar or equivalent to those described hereincan be used in the practice or testing of the present invention.

EXAMPLES

The present invention attempts to address these afore-noted problems inthe art. To that end, FIGS. 1A through 1C and 2A and 2B depict acannulated driver 1500 for a knotless anchor placement system of thepresent invention. Driver 1500 has a proximal handle 1502 in which isformed a proximal cylindrical recess 1504, and off-axis lateral holes1506, and a tubular distal portion 1510 having at its distal end tubulardrive element 1512. The distal portion 1514 of drive element 1512 isconfigured to be complementary to internal drive features 1602 in theproximal portion of the lumen of cannulated threaded anchor 1600;accordingly, torque supplied by driver 1500 is transmitted to anchor1600. The distal portion of drive element 1512 may be fabricated in avariety of sizes, shapes, configurations and lumen sizes to suit avariety of anchors 1600, the requirements for a particular anchor 1600depending on its size, configuration and material properties. Forexample, the complementary drive elements may take the form of aninternally or externally positioned hexagonal or square drive, aninternal or external spline, or slots positioned internal or external tothe anchor. However, the present invention contemplates alternatecooperating configurations and thus is not limited to any one particularembodiment.

Referring now to FIGS. 3 through 9 , cannulated tensioning device 1400has a proximal hub 1402 with a distal cylindrical portion 1404 in whichare formed off-axis lateral grooves 1406, and cleats 1408 formed in theproximal rim of proximal hub 1402. Tensioning device 1400 has a tubularmiddle portion 1410, and a tubular distal portion 1412, distal portion1412 having a diameter 1414 and length 1416. Diameter 1414 is selectedsuch that distal portion 1412 may be slidably positioned within distaldrive element 1512 of cannulated driver 1500. Length 1416 is determinedsuch that when tensioning device 1400 is positioned within the lumen ofthe cannulated driver 1500, distal portion 1412 of tensioning device1400 protrudes beyond distal drive element 1512 of driver 1500 asufficient distance so that when anchor 1600 is mounted on distal driveelement 1512 and distal portion 1412 is inserted to the full depth of asuitable socket formed in bone, anchor 1600 is still proximal to andclear of the socket. Elongate wire element 1302 having at its distal endloop 1304 and at its proximal end polymeric element 1306 forming a pulltab forms a loading loop 1300 for drawing sutures into the lumens oftubular members 1410 and 1412.

FIGS. 10 and 11 depict an illustrative embodiment of a removable key1200 that may serve to prevent relative axial and rotational movementbetween the cannulated driver and the tensioning device. In thisembodiment, key 1200 has a planar portion 1202 and cylindrical portions1204 that are sized and spaced such that cylindrical portions 1204 maybe inserted into off-axis lateral holes 1506 of handle 1502 ofcannulated driver 1500.

FIG. 12 depicts cannulated driver 1500 with anchor 1600 loaded thereto,tensioning device 1400 with loading loop 1300 positioned for loading asuture, and key 1200 prior to mounting of driver 1500 to tensioningdevice 1400 in preparation for use. When driver 1500 is mounted totensioning device 1400, off-axis slots 1406 of handle 1402 of tensioningdevice 1400 are aligned with off-axis holes 1506 of handle 1502 ofdriver 1500 and cylindrical portions 1204 of key 1200 are inserted intothe passages so formed. Positioning of key 1200 in this manner preventsaxial and rotational movement of tensioning device 1400 relative todriver 1500. FIGS. 13 through 19 depict knotless suture anchor system1000 of the present invention prepared for use with key 1200 and loadingloop 1300 in place.

Sutures 1800 are loaded into system 1000 by placing the proximal ends ofsutures 1800 in distal loop 1304 of loading loop 1300 as depicted inFIG. 20 . Tab 1306 of loading loop 1300 is withdrawn proximally untilproximal ends 1802 of sutures 1800 extend proximally beyond hub 1402 oftensioning device 1400 as depicted in FIG. 21 .

The present invention may be used to secure any type of soft tissue,graft, or tendon, such as, for example, a biceps tendon or a rotatorcuff. An illustrative method of fixation according to the principles ofthe present invention is depicted in FIGS. 22 through 32 .

FIG. 22 schematically depicts a socket 32 formed by drilling or punchingin bone 30, and a graft 20 to be affixed to bone 30. Sutures 1800 arepassed through graft 20 in a usual manner; and the sutures loaded intosystem 1000 as previously described and depicted in FIGS. 20 and 21,such that suture proximal ends 1802 are accessible to the surgeon.Subsequently, distal tubular portion 1412 of tensioning device 1400 isinserted into socket 32 as depicted in FIGS. 23 through 25 , the distalend of tubular portion 1412 contacting the bottom surface of socket 32.Thereafter, referring to FIGS. 26 through 28 , the surgeon graspsproximal ends 1802 of sutures 1800 and withdraws them proximally so asto advance graft 20 towards socket 32. When graft 20 is in the desiredposition, proximal ends 1802 of sutures 1800 are secured in cleats 1408to maintain the graft position. So long as proximal ends 1802 of sutures1800 remain securely cleated and the distal end of tubular element 1412is maintained in contact with the bottom surface of socket 32, theposition of graft 20 will not change. The surgeon may adjust sutures1800 as required to achieve optimal placement of graft 20. When thisoptimal placement of graft 20 has been achieved, while maintainingcontact between the distal end off distal tubular element 1412 and thebottom of socket 32, the surgeon removes key 1200 from system 1000 so asto allow axial and rotational movement of driver 1500. The surgeon thenadvances anchor 1600 to socket 32 and screws the anchor into socket 32so as to trap sutures 1800 between anchor 1600 and the wall of socket 32in bone 30 as depicted in FIGS. 29 through 31 . When anchor 1600 isfully inserted in socket 32, proximal ends 1802 of sutures 1800 arereleased from cleats 1408 and system 1000 is withdrawn from the joint,leaving the repair site as depicted in FIG. 32 . Subsequently sutures1800 are cut adjacent to anchor 1600 and the anchor placement iscomplete.

In an alternate method for anchor placement according to the presentinvention, the process may be simplified through use of an alternateembodiment in which the sutures are not drawn into a cannulation of thetensioning device, but rather are positioned and retained within aforked portion formed at the distal end of the tensioning device. Inthis alternate embodiment, sutures do not enter the lumen of thecannulated anchor, but rather wrap around the distal end of the anchorduring insertion and are retained in place by friction between theexternal surfaces of the anchor and the boney surface of the socket atlaterally opposed locations.

Such an alternate embodiment anchor placement system 2000 is depicted inFIGS. 33 through 42 and is identical to system 1000 in all aspectsexcept as specifically subsequently described. Specifically, in thisalternate embodiment, the cannulated distal tubular element 1412 ofsystem 1000 is replaced by distal element 2442 that is not cannulatedand has formed at its distal end elongate laterally opposed, distallyextending portions 2444 with sharpened distal ends 2448. Elongateportions 2444 form the tines of a fork with channel 2446 formed betweenportions 2444. Tensioning device handle 2402 has formed near the distalend of its external surface flanges 2430 wherein are formed slots 2432which serve as cleats for maintaining the tension of sutures placedtherein, flanges 2430 and slots 2432 replacing slots 1408 in hub 1402 ofsystem 1000.

A method of fixation according to the principles of the presentinvention using system 2000 is depicted in FIGS. 43 through 48 . Asocket 2032 is formed by drilling or punching in bone 2030. Sutures 2800are passed through graft 2020 in a usual manner. Sutures 2800 arepositioned within channel 2446 at the distal end of distal element 2442of the tensioning device and distal element 2442 is inserted into socket2032 such that the distal end of elongate portions 2444 contact thebottom of the socket as depicted in FIGS. 43 and 44 . Thereafter,referring to FIGS. 45 and 46 , the surgeon grasps proximal ends 2802 ofsutures 2800 and withdraws them proximally so as to advance graft 2020towards socket 2032. When graft 2020 is in the desired position,proximal ends 2802 of sutures 2800 are secured in cleats 2432 in flanges2430 of handle 2402 to maintain the graft position. So long as proximalportions 2802 of sutures 2800 remain cleated and the distal end ofdistal tensioning element 2442 is maintained in contact with the bottomsurface of socket 2032, the position of graft 2020 will not change. Thesurgeon may adjust sutures 2800 as required to achieve optimal placementof graft 2020. When this optimal placement of graft 2020 has beenachieved, while maintaining contact between the distal end off distaltubular element 2442 and the bottom of socket 2032, the surgeon removeskey 2200 from system 2000 so as to allow axial and rotational movementof the driver assembly. The surgeon advances anchor 2600 to socket 2032and screws the anchor into socket 2032 so as to trap sutures 2800between anchor 2600 and the walls of socket 2032 in bone 2030 asdepicted in FIG. 47 . When anchor 2600 is fully inserted in socket 2032,proximal portions 2802 of sutures 2800 are released from cleats 2432 andsystem 2000 is withdrawn from the joint. Subsequently suture proximalportions 2802 of sutures 2800 are cut adjacent to anchor 2600 and theanchor placement is complete. The position of the graft is maintained byfriction between the sutures 2800 that are trapped between the exteriorsurface of anchor 2600 and two laterally opposed portions of the wallsof socket 2032.

Anchor placement systems of the present invention are also useful forthe attachment of tendons in a procedure called bio-tenodesis. Whenattaching, for instance, a biceps tendon to the humeral shaft, theproximal end of the tendon is inserted into the socket and the implantplaced in a manner that traps the tendon between the anchor and the wallof the socket thereby retaining the tendon in the socket.

FIGS. 49 through 52 depict an alternate embodiment of a method forfixation of a tendon graft using system 2000. As is commonly done inpreparation for a bio-tenodesis type procedure, the portion of the graftthat is to be inserted into the socket is first sutured in acircumferential manner, the sutures providing added resistance topull-out when the repair is completed. Excess suture from thecircumferential suturing (also called “whip stitching”) is used toposition the tendon prior to anchoring by the implant. Unlike previousembodiment methods disclosed herein, the positioning of graft 3020 isnot achieved by tensioning the sutures after distal element 3442 isinserted into socket 3032. Rather, as depicted in FIG. 49 sutures 3802are positioned within channel 3446 at the distal end of distal element3442 of the tensioning device and tensioned such that graft 3020 ispositioned and retained adjacent to the distal end of distal element3442 adjacent to distally extending portions 3444. Tension in sutures3802 is then maintained by cleating in the manner previously hereindescribed. Thereafter, distal element 3444 is inserted into socket 3032as shown in FIG. 50 and anchor 3600 is placed as depicted in FIG. 51trapping graft 3020 between anchor 3600 and the boney surface of thewall of socket 3032 at a first location, and trapping sutures 3082between anchor 3600 and the boney surface of the wall of socket 3032 ata second location. Friction forces acting at these locations maintainthe position of graft 3020 relative to socket 3032 and bone 3030. FIG.52 depicts the site at completion of the anchor placement and removal ofinsertion system 3000.

FIGS. 53 through 57 depict an alternate method of anchoring a graft tobone using the alternate anchor placement system 2000 of the presentinvention. Rather than using tensioned sutures to maintain the placementof a graft at the distal end of distal element 3442 as previouslydepicted in FIG. 49 , the graft is impaled on the distally extendingportions 3444 of distal element 3442 as shown in FIGS. 53 and 54 , thesharpened distal ends 3448 of extending portions 3444 penetrating thegraft. Thereafter, distal element 3444 is inserted into socket 3032 asshown in FIG. 55 and anchor 3600 is placed as depicted in FIG. 56trapping graft 3020 between anchor 3600 and the boney surface of thewall of socket 3032. Friction force between the inserted portion ofgraft 3020 and socket 3032 maintains the position of graft 3020 relativeto socket 3032 and bone 3030. FIG. 57 depicts the site at completion ofthe anchor placement and removal of insertion system 3000. If the grafthas been whip-stitched and the excess suture remains, the suture tailswill also be trapped between anchor 3600 and socket 3032 therebyproviding additional resistance to pull out.

FIGS. 58 through 63 depict yet another alternate method for securing aligament graft to bone using anchor system 2000. As in the previousembodiments, sutures are not used to position and tension the graft 3020in socket 3032. Rather, as in the previous method, graft 3020 is impaledon the distally extending portions 3444 of distal element 3442 as shownin FIGS. 58 and 59 , the sharpened distal ends to of extending portions3444 penetrating the graft. The site for penetration is selected suchthat when the ligament is inserted to the bottom of socket 3032 theproximal end of graft 3020 protrudes above the rim of socket 3032. Asseen in FIG. 60 , graft 3020 is positioned above socket 3032, insertedas shown in FIG. 61 , and anchor 3600 placed as shown in FIG. 62 . FIG.63 shows the completed repair. Graft 3020 is trapped between theexterior surface of anchor 3600 and first and second laterally opposedportions of the wall of socket 3032 and retained in position by frictiontherefrom.

In certain instances, it may be useful to determine the tension in atendon undergoing a tenodesis procedure so that optimal tension may beselected and maintained based on the particular anatomy. Accordingly, inanother embodiment of the present invention, the inner tensioning membermay be provided with a mechanism that indicates the force being appliedto the graft during insertion into the socket. The insertion site on thegraft may be adjusted such that when the graft is inserted to the bottomof the socket the predetermined optimal tension is achieved, andthereafter maintained during anchor placement.

FIGS. 64 through 69 depict a distal assembly 4401 for a force-indicatingmechanism for use with an inner tensioning assembly in accordance withthe present invention. Elongate tubular element 4410 has at its distalend distal element 4442, identical to distal element 3442 (FIGS. 36through 40 ), and at its proximal end element 4450 affixed thereto.Element 4450 has a cylindrical outer surface portion 4452 and a planarouter surface portion 4454. The proximal end of tubular element 4410 isthen positioned within lumen 4456. Recess 4458 extends distally fromproximal-most surface 4451.

FIGS. 70 to 74 depict a handle 4402 for a force-indicating,inner-tensioning assembly. Handle 4402 is identical to handle 2402 inall aspects except as subsequently described. Specifically, handle 4402has a distal lumen 4491 with a diameter that allows tubular element 4410to be slidably positioned therein. Recess 4496 extends distally fromproximal-most surface 4403 of handle 4402 and has a cylindrical surfaceportion 4497 and a planar portion 4498 sized such that element 4450 maybe positioned therein. This construction is such that when distalassembly 4401 is assembled to handle 4402 with element 4450 positionedwithin recess 4496 and tubular member 4410 is positioned within lumen4491 of handle 4402, distal assembly 4401 may be move axially relativeto handle 4402 but rotation is prevented. Handle 4402 has a window 4490formed in its top surface with adjacent beveled surfaces 4492 so thatrecess 4496 and elements therein may be viewed.

FIGS. 75 through 79 depict a proximal end cap 4700 for handle 4402. Endcap 4700 has a distal portion 4702 with proximally extending recess4704, and a proximal portion 4706. Distal portion 4702 is configured forassembly to handle 4402.

Referring now to FIGS. 80 through 84 , which depict an assembledforce-indicating anchor system 4000 of the present invention, distalassembly 4401 may be assembled to handle 4402 as previously described,and end cap 4700 is assembled to the proximal end of handle 4402. Spring4900 is positioned therebetween with its distal end in recess 4458 ofelement 4450 and its proximal end in recess 4704 of end cap 4700. Asseen in FIG. 81 , indicia 4470 are formed on beveled surfaces 4492 suchthat the position of proximal-most surface 4451 of element 4450 visiblethrough window 4490 may be quantified. The position of element 4450 andits proximal-most surface 4451 is determined by the amount of deflectionof spring 4900, which is in turn determined by the force exerted ondistal assembly 4401. This force is exerted on distal assembly 4401 bytension in the graft during insertion into a socket by distal element4442. Device 4000 may be calibrated so that during insertion of thegraft into the socket by the surgeon, by observing the position ofproximal-most surface 4451 relative to the indicia, will know theinsertion force and thereby the tension in the graft.

When using embodiments previously herein described, the inner tensioningdevice is maintained in a non-rotating condition with respect to theouter driver device by means of the surgeon's hand placed on theproximal hub of the inner tensioning device. The surgeon's hand on theproximal hub also maintains contact between the distal end of thetensioning device and the bottom of the prepared socket by applyingdistal force to the hub. To advance the outer driver device and theanchor removably mounted thereto into the prepared socket and to placethe anchor therein, the surgeon must first uncouple the driver from thetensioning device, then move the driver axially to position the anchorat the socket, and then finally screw the implant into the socket. Sincethe surgeon must maintain the position of the tensioning device whendoing performing any actions with the driver, this method requires theuse of both of the surgeon's hands.

However, other embodiments of the present invention contemplateperformance of these functions with a single hand. For example, ratherthan being supplied by the surgeon's hand, the forward force on thetensioning device (or “inner assembly”) may alternatively be supplied byan elastic member that is integral with or constitutes a part of theinner assembly. Rotation of the inner tensioning assembly is thusprevented by contact between the distal end of the tensioning device andthe bottom surface of the prepared socket in which the implant is to beplaced.

FIGS. 85 through 88 depict driver/outer assembly 5500 and implant 5600for an alternate embodiment implant placement system of the presentinvention configured for one-handed operation by a surgeon. Driver 5500and implant 5600 are identical in all aspects of form to driver 1500 andimplant 1600 (FIGS. 1 through 2B) except as hereafter specificallydescribed. For example, off-axis holes 1506 of handle 1502 of driver1500 are eliminated, as are the planar regions in which they intersect.Proximal cylindrical recess 5504 extends distally to intersect verticalcylindrical recess 5534 which is configured to receive a slidablecontrol element, the upper portion of vertical recess 5534 beingconfigured to receive retainer 5530 with coaxial opening 5532.

Inner assembly 5400, depicted in FIGS. 89 through 91B, is identical inform to tensioning device/inner assembly 1400 depicted in FIGS. 3through 8 except as specifically hereafter described. For example, thedistal cylindrical portion 1404 with off-axis lateral grooves 1406 ofhub 1402 of tensioning device 1400 is eliminated. In its stead, innertensioning assembly 5400 has distally adjacent to hub 5402, assembly5450 formed of proximal element 5452 and distal element 5458 with spring5454 positioned therebetween as depicted in FIG. 91A. Proximal element5452 and distal element 5458 are rotatably and slidably positioned ontubular middle portion 5410. Positioned distal to distal element 5458and separated therefrom by washer 5462 (FIG. 91B), element 5456 isaffixed to tubular middle portion 5410. Element 5456 has a proximalportion 5476, a middle portion 5470 of reduced diameter forming acircumferential channel bounded by proximal wall 5466 and distal wall5468, and a distal portion 5472 having a distal end on which is formedchamfer 5474.

FIGS. 92 and 93 depict a slidable control element 5200 configured to beslidably received within vertical cylindrical recess 5534 of handle 5502of driver 5500, and retained therein by retainer 5530. Control element5200 has an upper portion 5210 sized to be slidably received withinopening 5532 of retainer 5530, a mid portion 5212 and a lower portion5220. Mid portion 5212 has formed therein symmetrically opposed first(distal) flat 5216 and second (proximal) flat 5214 with cylindrical hole5218 extending therebetween.

The elements of this alternate embodiment implant placement system 5000of the present invention comprising outer driver assembly 5500, innertensioning assembly 5400, and control element 5200 are depicted in FIG.94 . Slidable control element 5200 with spring 5230 is inserted intovertical cylindrical recess 5534 and retained therein by retainer 5530.Inner assembly 5400 is inserted into proximal cylindrical recess 5504and proximal element 5452 is affixed to the proximal end of handle 5502.

FIGS. 95 through 99 depict implant placement system 5000 assembled andready for use. Proximal element 5452 of inner assembly 5450 (see FIG. 94) is affixed to the proximal end of outer driver assembly 5500 handle5502. Control element 5210 is depicted in a first position wherein upperportion 5210 of control element 5200 protrudes above the top surface ofretainer 5530 and is maintained in that position by spring 5230. In thisfirst position, distal travel of outer driver assembly 5500 relative toinner tensioning assembly 5400 is constrained by contact between distalfacing surface 5466 of proximal portion 5476 of element 5456 andproximal surface 5214 of control element 5210, and initial compressionbeing imparted to spring 5454 thereby. Distal element 5412 of innertensioning assembly 5400 protrudes beyond implant 5600 a sufficientdistance to reach to bottom of a prepared socket while implant 5600remains proximal to the socket. As depicted in FIGS. 98A through 98C,when a proximal force is applied to distal element 5412 of innerassembly 5400 as when tensioning sutures for implant placement, proximalmotion of inner tensioning assembly 5400 relative to outer driverassembly 5500 is prevented by contact between proximal surface 5468 ofdistal portion 5472 of element 5456 affixed to tubular middle portion5410, and distal surface 5216 of control element 5210.

Applying a downward force to slide control 5200 sufficient to compressspring 5230 brings opening 5218 in slide control mid portion 5212 intocoaxial alignment with tubular mid portion 5410 and element 5456 mountedthereto such that distal portion 5472 of element 5456 may passtherethrough allowing outer driver assembly 5500 to advance distallyrelative to inner tensioning assembly 5400 to its distal limit asdepicted in FIGS. 100 through 104 . Spring 5454 is compressed asdepicted in FIG. 103 . When slide 5200 is positioned as shown, outerdriver assembly 5500 may be advanced distally with resistance to thisaxial movement provided by force supplied by spring 5454. Outer driverassembly 5500 may also be simultaneously freely rotated relative toinner tensioning assembly 5400. Referring to FIGS. 98B and 98C, distalelement 5458, washer 5462 and proximal portion 5476 of element 5456together form a bearing, distal element 5456 and washer 5462 beingformed of a metallic material and optionally having a suitable lubricantapplied to their mating surfaces as well as on tubular mid portion 5410of inner tensioning assembly 5400.

Implant placement system 5000 places implant 5600 in the same manner assystem 1000 in that sutures passing through the graft are tensionedusing a non-rotating distal tensioning element that protrudes distallybeyond the implant a sufficient distance to allow the distal end of thedistal tensioning element to reach the bottom of a prepared socket withthe implant remaining proximal to the socket. Unlike system 1000, inwhich rotation of inner tensioning assembly 1400 is prevented by thesurgeon's control of hub 1402, prevention of rotation of innertensioning assembly 5400 is prevented by cooperative interaction betweenthe distal end 5413 of distal element 5412 of inner tensioning member5400 and the cortical bone at the bottom of the socket. The consistencyof the cortical bone at the bottom of a socket is such that it may bedeformed by distal end 5413 of distal element 5412 and by suturespassing into the cannulation of distal element 5412 due to axial forceapplied by the surgeon. This deformation increases the frictionalresistance to rotation of distal element 5412 and inner tensioningassembly 5400 of which it is a part. This resistance to rotation may befurther enhanced through the forming of suitable contours on distal end5413 of distal element 5412 so as to create features that may penetratethe cortical bone or create localized depressions therein. Thesecontours may include, for instance, protuberances, grooves, orcurvilinear shapes. Like implant system 1000, system 5000 has cleats5408 formed in inner tensioning assembly hub 5402 for maintaining thetension on sutures during placement of the implant. In otherembodiments, cleats 5408 are not formed in hub 5402 and the suturetension is maintained through friction between the cortical bone at thebottom of the socket and distal end 5413 of distal tensioning element5412 between which it is trapped.

When placing anchor 5600, the surgeon does not control inner tensioningassembly 5400 through hub 5402, but rather controls placement processexclusively through handle portion 5502 of outer driver assembly 5500and slide control 5320.

When using implant placement system 5000, suture is loaded intotensioning inner assembly 5400 as depicted in FIGS. 20 and 21 forimplant system 1000. Thereafter, anchor 5600 is placed as depicted inFIGS. 22, 25, 28, 31 and 32 . In figures referenced in the followingdescription, depicted elements of implant system 1000 designated as“1XXX” may be replaced by their corresponding elements of implant system5000 designated as “5XXX”. FIG. 22 schematically depicts a socket 32formed by drilling or punching in bone 30, and a graft 20 to be affixedto bone 30. Sutures 1800 are passed through graft 20 in a usual manner;and the sutures loaded into system 5000 as previously described anddepicted in FIGS. 20 and 21 , such that the suture proximal ends areaccessible to the surgeon. Subsequently, distal tubular portion 5412 oftensioning inner assembly 5400 is inserted into socket 32 as depicted inFIGS. 23 through 25 , the distal end of tubular portion 5412 contactingthe bottom surface of socket 32. Thereafter, referring to FIGS. 26through 28 , the surgeon grasps the proximal ends of sutures 1800 andwithdraws them proximally so as to advance graft 20 towards socket 32.When graft is in the desired position, the proximal ends of sutures 1800are secured in cleats 5408 (FIG. 95 ) to maintain the graft position. Solong as the proximal ends of sutures 1800 remain securely cleated andthe distal end of tubular element 5412 is maintained in contact with thebottom of socket 32, the position of graft 20 will not change. Thesurgeon may adjust sutures 1800 as required to achieve optimal placementof graft 20. When this optimal placement of graft 20 has been achieved,while applying distal force to handle 5502 of implant system 5000 so asto maintain contact between the distal end off distal tubular element5412 and the bottom of socket 32, the surgeon moves slide control 5300to its second position (see FIG. 103 ) thereby allowing outer driverassembly 5500 with implant 5600 mounted thereto to be moved distally soas to bring implant 5600 to socket 32, and to be rotated so as to thenthread implant 5600 into socket 32 so as to trap sutures 1800 betweenanchor 5600 and the wall of socket 32 in bone 30 as depicted in FIG. 31. When anchor 5600 is fully inserted in socket 32, the proximal ends ofsutures 1800 are then released from cleats 5408 and system 5000 iswithdrawn from the joint, leaving the repair site as depicted in FIG. 32. Subsequently sutures 1800 are trimmed adjacent to anchor 5600 and theanchor placement is complete. Upon withdrawal of implant placementsystem 5000 from the site, outer driver assembly 5500 is returned to itsproximal position (FIGS. 95 through 99 ) by force supplied by spring5454, chamfered end 5474 of distal portion 5472 of element 5456 andopening 5218 cooperatively acting to return control slide 5200 to itsfirst position.

The initial compression applied to spring 5454 when assembled as shownin FIGS. 95 through 99 , with outer driver assembly 5500 in itsproximal-most position, is sufficient to ensure that, after tensioningsutures 1800 in socket 32 prior to placing implant 5600, when slidecontrol 5320 is moved to its second position to allow outer driverassembly 5500 to move distally to bring the implant to the socket and toscrew the implant into the socket, distal end 5413 of distal tensioningelement 5412 remains firmly in contact with the cortical bone at thebottom of socket 32 so as to prevent rotation of inner tensioningassembly 5400.

In the method of implant placement previously described using placementsystem 5000, the tension in sutures 1800 and graft position aremaintained by removably storing the suture proximal ends in cleats 5408of inner tensioning assembly 5400. In an alternate method for placinganchor 5000, the tension in sutures 1800 and graft position aremaintained by the surgeon applying tension to the proximal ends ofsutures 1800, or by friction force applied to the portions of sutures1800 trapped between distal end 5413 of distal tensioning element 5412and the cortical bone at the bottom of socket 32, or by a combination ofthese two methods.

In an alternate embodiment, a loop of an elongate element such as, forinstance, nitinol wire may be formed distal to the distal end 5413 ofdistal tensioning element 5412 (see FIG. 99 ) with the proximal ends ofthe elongate element removably secured in cleats 5408 of hub 5402.Sutures may be loaded into the nitinol loop, tensioned, and secured byan anchor, whereupon the elongate element is removed. This method ofimplant placement is described in detail in inventors' own U.S. Pat. No.9,770,240 referenced above, entitled “Ceramic Implant Placement SystemsAnd Superelastic Suture Retention Loops For Use Therewith”, the contentsof which have been previously incorporated by reference in theirentirety.

FIG. 105 shows an exploded assembly of the elements of an alternateembodiment implant placement system of the present invention. Implantplacement system 6000 is identical in all aspects of form and functionto implant placement system 5000 except as specifically describedhereafter. For example, cannulated distal tensioning element 5412 ofsystem 5000 is replaced by distal tensioning element 6412 which is aliketo distal element 2412 (FIGS. 36 through 38) of implant placement system2000. Spring 5230 (FIG. 94 ) is eliminated such that slide control 6200may be positioned and remain in a first position in which axial motionof outer driver assembly 6500 is prevented (FIGS. 106A through 110 ), ormay be placed and remain in a second position in which the outer driverassembly 6500 may be advanced distally against force supplied by spring6454 (FIGS. 111 through 115 ). Hub 5402 of inner tensioning assembly5400 is eliminated, the rotation of inner assembly 6400 being controllednot by the surgeon's hand on a proximal hub, but rather throughinteraction between the distal end of distal tensioning element 6412 andthe cortical bone at the bottom of the prepared socket. Maintaining theposition of the distal end of distal tensioning element 6412 at thebottom of the prepared socket is not accomplished through distal forceapplied to a hub like hub 2402 of the inner tensioning assembly 2400 aswhen using implant placement system 2000, but rather through distalforce applied to handle 6502 of outer driver assembly 6500 and anelastic element acting between inner tensioning assembly 6400 and outerdriver assembly 6500.

FIGS. 106A through 110 depict slide control 6200 in a first positionwith its topmost surface 6201 protruding above the top surface ofretainer 6530. In this configuration, distal axial movement of outertensioning assembly 6500 is prevented by interaction between slidecontrol 6200 and element 6456 of inner tensioning assembly 6400 in themanner previously herein described with reference to implant placementsystem 5000. As with implant placement system 2000 (FIGS. 33 to 42 ),distal tensioning element 6412 has formed thereon distally extendingportions 6444 separated by a gap 6446, distally extending portions 6444having sharpened distal ends 6448, the distal end of distal tensioningelement 6412 having the form of a fork. Sharpened distally extendingportions 6444 are configured so as to be able to pierce tissue orcortical bone, and gap 6446 is configured so that sutures placed thereinmay be made to slide smoothly for the purpose of tensioning a graft.

With slide control in its second position as depicted in FIGS. 111through 115 , outer driver assembly 6500 of implant placement system6000 may be moved distally so as to bring implant 6600 mounted theretoto a prepared socket after the position of a graft is established, andsubsequently threaded into the socket. Top surface 6201 of slide control6200 is coplanar with the upper surface of retainer 6530 while bottomsurface 6203 of slide control 6500 protrudes beyond the adjacent surfaceportion of handle 6502 of outer driver assembly 6500.

To summarize, with slide control 6200 in its first position, axialmovement of driver assembly 6500 is prevented. With slide control 6200in its second position driver assembly 6500 rotates freely and may bemoved distally relative to inner tensioning assembly 6400, the axialmotion being resisted by spring 6454. In contrast to earlier describedembodiments, slide control 6200 is not returned to its first position bya spring, but rather will remain in its second position until returnedto its first position by the surgeon.

The method for placing an implant in accordance with the principles ofthe present invention is the same as the method when using implantplacement system 2000 and depicted in FIGS. 44 and 46 through 48 exceptas subsequently herein described. To that end, in figures referenced inthe following description, depicted elements of implant system 2000designated as “2XXX” may be replaced by their corresponding elements ofimplant system 6000 designated as “6XXX”. Slide control 6200 of implantplacement system 6000 is initially in its first position and thecondition of system 6000 is as depicted in FIGS. 106A through 110 .Sutures 2802 are captured in gap 6446 between distally extendingportions 6444 at the distal end of distal tensioning element 6412 (seeFIG. 106B) and inserted with distal tensioning element 6412 into socket2032 as depicted in FIG. 44 . Thereafter, as shown in FIG. 46 , tensionis applied to sutures 2802 to bring graft 2000 to the present position.The surgeon maintains this tension so as to maintain the graft position.The surgeon then moves slide control 6200 to its second position andadvances outer driver assembly 6500 with implant 6600 mounted theretodistally to bring implant 6600 to socket 2032, and then threads implant6600 into socket 2032 as shown in FIG. 47 . Distal force applied toimplant placement system 6000 via handle 6502 of outer driver assembly6500 causes sufficient interference between distal end features ofdistal tensioning element 6412 to prevent rotation of inner tensioningassembly 6400 during subsequent threading of anchor 6600 into socket2032. Compression of spring 6454 of inner tensioning assembly 6400applies sufficient distal force to ensure that contact is maintainedbetween the distal end of distal tensioning element 6412 and thecortical bone at the bottom of socket 2032. With implant 6600 threadedinto position as depicted in FIG. 47 , the condition of implant system6000 is as depicted in FIGS. 111 through 115 . FIG. 48 depicts the siteat the completion of implant placement.

With slide control 6200 in its first position, axial movement of driverassembly 6500 of implant placement system 6000 is prevented. With slidecontrol 6200 in its second position driver assembly 6500 rotates freelyand may be moved distally relative to inner tensioning assembly 6400,the axial motion being resisted by spring 6454. As noted above, contrato earlier embodiments, slide control 6200 is not returned to its firstposition by a spring, but rather may remain in its second positionthereby giving the surgeon the option of inserting distal tensioningelement 6412 into a prepared socket and positioning the graft throughthe adjustment of suture tension while relying solely on the forcesupplied by spring 6454. The resisting force supplied to outer driverassembly 6500 by spring 6454 is sufficient to allow tensioning ofsutures as previously herein described.

Implant placement system 6000 is depicted with inner assembly 6400having distal tensioning element 6412 with its distally extendingportion 6444. Inner assembly 6400 may be replaced by inner assembly 5400with its cannulated distal tensioning element 5412 and hub 5402 withoutdeparting from the principles of the present invention.

In previously described embodiments of the present invention, theanchors placed were threaded and placed by torque applied by the driver.In other embodiments, the implants placed are interference plug-typeanchors (often referred to as “push-in” implants) that are not threaded,but rather are configured for placement in a prepared socket by axialforce supplied by the driver. Such implants are well known in the artand have a plurality of axially spaced conical portions formed on theircylindrical outer surface so as to allow ease of placement in thesocket, while providing substantial resistance to axial removal.

An alternate embodiment of the present invention suitable for use withsuch “push-in” implants and incorporating a simplified construction isdepicted in FIGS. 116 through 126 . Implant placement system 7000 isidentical in form and function to implant placement system 6000 exceptas specifically described hereafter. For example, control slide 6200 ofimplant placement system 6000 is eliminated so that outer driverassembly 7500 of placement system 7000 may be advanced distally in thesame manner as outer driver assembly 6500 of implant placement system6000 when control slide 6200 is in its second position. Implant 7600 isa push-in (interference plug) type anchor which does not have a helicalthread formed on its outer surface, but rather a plurality of taperedportions (best seen in FIG. 121 ). Implant 7600 has a planarproximal-most surface. Distal element 7512 of outer driver assembly 6500has a planer distal-most surface configured for transmitting axial forceto implant 7600 during the placement of implant 7600. Push-in typeimplants and their use with embodiments of the present invention aredescribed in U.S. Pat. No. 9,770,240 referenced and incorporated above.As noted elsewhere herein, push-in implants of the present invention maybe formed of high strength ceramic materials.

FIG. 116 is a perspective view of an exploded assembly of the elementsof implant placement system 7000. Outer driver assembly 7500 is of asimple form with no external control means. FIGS. 117 to 121 depictimplant placement system 7000 with outer driver assembly 7500 in itsfully proximal position, maintained therein by spring 7454 of innertensioning assembly 7400. As seen in FIG. 120 , element 7456 does nothave features for cooperative engagement with a slide control, butrather has a planar distal surface 7457. Cylindrical recess 7504 ofouter driver portion handle 7502 has a distal-most surface 7505 which,together with distal surface 7457 of element 7456, establishes theproximal limit of travel of outer driver assembly 7500 relative to innertensioning assembly 7400. As with implant placement systems 5000 and6000, the force supplied by spring 7454 is sufficient to prevent distaltravel of outer driver assembly 7500 during tensioning of sutures forpositioning of a graft.

FIGS. 122 through 126 depict implant placement system 7000 with outerdriver assembly at the distal limit of its travel as when implant 7600is fully placed in a prepared socket. Upon removal of implant placementsystem 7000 from the site at the completion of placement of implant7600, outer driver assembly 7500 returns to its proximal-most positionas depicted in FIGS. 117 to 121 .

Implant placement system 7000 is used in the same manner as system 6000previously herein described except as subsequently described. Forexample, the surgeon is not required to move slide control 6200 to itssecond position prior to advancing implant 7600 to the prepared socket.The surgeon is thus able to place implant 7600 with a first handsupplying tension to the sutures for graft positioning, and a secondhand, via handle 7502 of outer tensioning assembly 7500, insertingdistal tensioning element 7412 into a prepared socket, and thereaftermaintaining the position of element 7412 during positioning of a graft.When the graft is properly positioned, implant 7600 is incrementallydriven axially into the prepared socket by repeatedly impacting proximalend cap 7452 with a mallet. When implant 7600 is fully inserted,placement system 7000 is removed from the site and the repair iscompleted.

While methods of use of implant systems 5000, 6000 and 7000 have beendescribed with reference to placing an implant so as to maintain a graftposition by the trapping of sutures between the implant and at least onewall of the socket, these systems may also be used for bio-tenodesisprocedures as depicted in FIGS. 49 through 52 , FIGS. 53 through 57 ,and FIGS. 58 through 63 as well as other embodiments contemplated by thepresent invention.

In systems 5000, 6000 and 7000 previously herein described, resistiveforce from a spring prevents the tensioning assembly from movingproximally during placement of an implant in a prepared socket followingtensioning of a graft. In other embodiments, the resisting force issupplied not by a spring, but rather by friction supplied by elementswithin the implant system. This frictional resistance may be supplied bya single element for which the only function is supplying a resistingfrictional force, or by existing elements within the system assembly, orby a combination of the two.

Alternate embodiment system 8000 uses frictional force to preventproximal movement of the insertion/tensioning assembly during implantplacement. System 8000 is like system 5000 in all aspects of form andfunction except as subsequently described. Referring to FIGS. 127through 129 , inner assembly 8400 is inner assembly 5400 (FIGS. 89through 91 ) except that spring 5454, and associated elements 5458, 5460and 5462 are eliminated. Friction producing element 8453 is mounted tothe distal end of proximal element 8452. Element 8453 suppliesfrictional resistance to relative movement of the inner tensioningassembly 8400 relative to the outer driver assembly. The outer driverassembly is identical to outer assembly 5500 depicted in FIGS. 85through 88 .

Referring now to FIGS. 130 and 131 depicting system 8000 wherein distalelement 8412 of tensioning/insertion assembly 8400 is extended distallybeyond implant 8600 for tensioning sutures in preparation for implantplacement, and FIGS. 132 and 133 wherein inner tensioning assembly 8400is positioned as at the completion of implant placement. System 8000 isused in the same manner as system 5000 previously herein described.After passing sutures through a graft, the distal element 8412 isinserted into a prepared socket and the sutures tensioned for propergraft position and cleated. Thereafter, slide control 8200 isrepositioned so as to allow the outer driver assembly to advance implant8600 to the socket in preparation for placement. The friction forcesupplied by element 8453 acting on tubular middle portion 8410 of innertensioning assembly 8400 is sufficient to maintain the position of theinner tensioning assembly and distal element 8412 such that the tensionof the sutures is maintained and rotation of the inner tensioningassembly is prevented during anchor placement. When using implantplacement system 5000, the outer driver assembly 5500 is returned to itsproximal position by force supplied by spring 5454. When using implantplacement system 8000 the surgeon must manually return the outer driverassembly to its proximal position by grasping distal element 8412 ofinner tensioning assembly 8400 and pulling it back to its distallyextended position. Thereafter another implant 8600 may be mounted to thesystem and placed as previously described.

Tensioning element 8453 may be formed of a metallic or polymericmaterial. In a preferred embodiment tensioning element 8453 is formed ofa resilient polymeric material. Tensioning element 8453 may be ofunitary construction, or may be an assembly. In some embodiments element8453 is formed of an assembly of metallic elements. In other embodimentstensioning element 8453 is an assembly of rigid and resilient polymericmaterials, the resilient polymeric material contacting middle portion8410 of inner tensioning assembly 8400 so as to provide suitablefrictional resistance therebetween.

While the use of tensioning element 8453 is described as applied tosystem 8000, which is a modification of system 5000 with its innercannulated tensioning assembly 5400, tensioning element 8453 may beapplied to systems 6000 and 7000 as well. Springs 6454 of system 6000and 7454 of system 7000 with their associated elements may be eliminatedand resistance to relative axial motion between the inner tensioningassembly and outer driver assembly supplied by a friction resistanceelement like element 8453 of system 8000.

Implant placement system 9000, depicted in FIGS. 134 through 139 , isidentical to system 6000 (FIGS. 105 through 115 ) in all aspects of formand function except as hereafter described. Specifically, spring 6454,and associated elements 6458, 6460 and 6462 are eliminated. Proximalelement 6452 of inner assembly 6450 is modified as depicted in FIGS. 134through 137 . Lumen 9459 of proximal element 9452 has a proximal portion9455 with a diameter larger than that of middle element 9410, and adistal portion 9457 in which the diameter is reduced such that thedistal portion of lumen 9459 contacts middle element 9410 so as tocreate a frictional resistance to axial movement between the elements. Aplurality of slots 9451 creates resilient, distally extending regionstherebetween, the geometry of these regions determining the contactforce exerted thereby on middle element 9410 and the resultingfrictional resistance to relative movement therebetween. System 9000 isused in the same manner as system 6000 except that after placement of animplant, the surgeon the outer driver assembly is returned to itsproximal position in preparation for placing another anchor by pullingdistal element 9412 of inner tensioning assembly 9400 to its full distalextension. Thereafter another implant 9600 may be loaded onto the system9000 in preparation for placement. The modifications made to system 6000to form placement system 9000 may be advantageously made to systems 5000and 7000 as well.

In systems 8000 and 9000, the friction-producing means is proximallylocated in the handle of the systems. In other embodiments, thefriction-producing device may be located distally. For example, insystem 10000, the distal portion of which is shown in FIGS. 140 through142 , annular ring 10011 provides frictional resistance to theadvancement of implant 10600 and the associated outer driver assemblyfollowing tensioning of a suture and during implant placement. Annularring 10011 is preferably formed from a suitable biocompatible polymericmaterial. Annular ring 10011 remains in the socket distal to implant10600 at the completion of placement of implant 10600. Torquetransmission from the distal end of implant 10600 to distal element10412 of the inner tensioning assembly is minimal and insufficient tocause rotation of distal element 10412 during implant placement.

In other embodiments of the present invention, the frictional resistanceto moving may be supplied by the distal element, for example by distaldrive element 5512 of outer driver assembly 5500 of system 5000 in FIG.85 . In other embodiments, the frictional resistance force isdistributed throughout the assembled components so that no singleelement provides the total frictional resistance.

Anchor placement system 2000, depicted in FIGS. 33 through 42 , may beused as in FIGS. 43 through 52 wherein sutures are retained withinchannel 2446 between distally extending portions 2444 of distal element2442 of tensioning device 2400, or as in FIGS. 53 through 63 whereindistally extending portions 2444 pierce the graft for insertion of thegraft into the socket for anchor placement. In other embodiments of thepresent invention, the distal end of the distal element of thetensioning device is optimized for use in the manner of FIGS. 43 through52 wherein sutures are retained at the distal end of the tensioningdevice.

For example, FIGS. 143 through 145 depict distal element 12442 that isalike in form and function to distal element 2442 (FIGS. 36 through 40 )and all corresponding non-cannulated distal elements with distal forkportions previously herein described in all aspects except asspecifically subsequently described herein. Specifically, distallyextending portions 12444 has distal portions 12445 that extend mediallyat their distal ends so that channel 12446 formed between distallyextending portions 12444 forms an eyelet having a gap 12447 in itsdistal end. Some current repair techniques for attaching a graft to aboney surface anchor utilize multiple strands of suture with a singleimplant. Accordingly, it may be desirable to affix as many as sixsutures with a single implant. The length of distally extending portions12444 may thus be extended thereby increasing the size of channel 12446to accommodate a desired number of suture strands.

Another alternate embodiment 22000, the distal portion of which isdepicted in FIGS. 146 through 148 , has a resiliently deformablepolymeric distal element 22443 affixed to the distal end of element22442. Like distally extending portions 12444 of the distal portion ofdistal element 12442, distally extending portions 22444 of polymericdistal element 22443 are configured for the retention of suturestherebetween, the distal portions of extending portions 22444 curvinginward to form a distal gap 22447 between their distal ends. Becausedistally extending portions 22444 are formed of a resiliently deformablepolymeric material, maximum width 22445 across portions 22444 may exceedthe diameters of the lumen of implant 22600, distally extending portions22444 deforming inward to allow withdrawal of distal elements 22442 and22443 from implant 22600 after placement, or for the reinsertion ofthese elements for implant removal and reinsertion. In a preferredembodiment, distal element 22443 is formed of PEEK or a similarresilient polymeric material. In other embodiments, distally extendingelements 22444 are formed of a super-elastic metallic material such asnitinol.

The distally extending portions of the distal end of the distaltensioning element may be rigid, resilient, elastically or inelasticallydeformable, integral with the distal tensioning element, affixed to thedistal end thereof or positioned within a lumen thereof, and formed of ametallic or nonmetallic material. All fall within the scope of thisinvention.

FIGS. 149 and 150 depict a depth-limiting element 32001 formed of asuitable metallic or polymeric material for use with implant placementsystem 2000 (FIGS. 33 through 42 ) when used for attachment of a softtissue graft to bone as depicted in FIGS. 53 through 57 and FIGS. 58through 63 .

Referring now to FIGS. 53 through 57 , wherein graft 3020 is impaled ondistally extending portions 3444 of distal element 3442 and thereafterinserted into socket 3032 prior to the placement of implant 3600, theforce required to insert graft 3020 may be sufficient to cause failureof graft 3020 at the impalement site. Specifically, the distal end ofdistal element 3442 may excessively penetrate graft 3020 so as to teargraft 3020 such that graft 3020 slides proximally up distal element 3442rather than being inserted into socket 3032. The depth of penetration ofdistal element 3442 into graft 3020 may be limited by depth limitingelement 32001.

Referring to FIGS. 149 and 150 , element 32001 has formed therein slots32003 configured for removable mounting to distally extending portions3444 of distal element 3442. Referring now to FIGS. 151 through 154 ,the distal portion of alternate embodiment system 32000 is identical inall aspects to system 3000 depicted in use in FIGS. 53 through 57 and 58through 63 and in all aspects of form and function except that depthlimiting element 32001 is removably affixed to distally extendingportions 32444 of distal element 32442. As described and depicted ininventors' own U.S. Pat. No. 9,566,060 (formerly U.S. application Ser.No. 15/012,060 to which the instant applications claims priority as acontinuation-in-part), in an alternate embodiment placement system42000, the distal portion of which is depicted in FIGS. 155 and 156 ,distally extending portions 32444 of placement system 32000 may bereplaced by a single distally extending portion 42444 configured forpiercing of a soft tissue graft. Depth-limiting element 42001 isconfigured for removable mounting to the distal end of elongate distalelement 42442.

Placement system 42000 may be used in the same manner for attaching agraft to a boney surface as system 3000 depicted in FIGS. 53 through 57. The method for fixation of graft 3020 to boney surface 3030 is alikein all aspects of form and function except as specifically hereindescribed and depicted in FIGS. 157 through 161 . Socket 3032 is formedin boney surface 3030 in a predetermined location. Depth-limitingelement 42001 is removably affixed to the distal end of elongate distalportion 42442 of placement system 42000. As depicted in FIGS. 157through 161 , whip stitches 3021 have been placed in the distal portionof graft 3020. Whip stitches 3021 are optionally added to increase theresistance of the completed construct to failure due to tensile load andare not a required element of forming a construct in accordance with theprinciples of the present invention. Graft 3020 is impaled on thedistally extending portion 42444 of distal element 42442 as shown inFIGS. 157 and 158 , depth limiting element 42001 limiting the depth ofpenetration of distally extending portion 42444 into graft 3020.Thereafter, distal element 42444 is inserted into socket 3032 as shownin FIG. 159 with depth limiting element 42001 preventing additionalpenetration of graft 3032 due to the force applied during insertion.Anchor 42600 is placed as depicted in FIG. 160 trapping graft 3020between anchor 42600 and the boney surface of the wall of socket 3032.Friction force between the inserted portion of graft 3020 and socket3032 maintains the position of graft 3020 relative to socket 3032 andbone 3030. Optional whip stitches 3021 increase the resistance tomovement of graft 3020 relative to socket 3032 when a tension force isapplied to graft 3020. FIG. 161 depicts the site at completion of theanchor placement and removal of insertion system 42000. Depth limitingelement 42001 remains in the construct adjacent to the distal end ofimplant 42600, between implant 42600 and graft 3020.

An alternative method for affixing a soft tissue graft to a boneysurface using placement system 42000 is like the placement methoddepicted in FIGS. 58 through 63 in all aspects of form and functionexcept as specifically described below and depicted in FIGS. 162 through167 . Depth-limiting element 42001 is removably affixed to the distalend of elongate distal portion 42442 of placement system 42000. Asdepicted in FIGS. 162 through 167 , optional whip stitches 3021 havebeen formed in the distal portion of graft 3020. A preferred method ofaffixing graft 3020 to boney surface 3030 thereafter has the followingsteps. Socket 3032 is formed in boney surface 3030 at a predeterminedlocation. Graft 3020 is impaled on the sharpened distally extendingportion 42444 of distal element 42442 as shown in FIGS. 162 and 163 ,the sharpened distal end of distally extending portion 42444 penetratingthe graft with the depth of penetration being limited by depth limitingelement 42001. The site for penetration is selected such that when thedistal portion of graft 3020 is inserted to the bottom of socket 3032the distal end of graft 3020 protrudes above the rim of socket 3032. Asseen in FIG. 164 , graft 3020 is positioned above socket 3032 andinserted as shown in FIG. 165 . Depth limiting element 42001 preventspenetration of graft 3020 by distal element 42442 during insertion dueto the insertion force applied. Thereafter, anchor 42600 placed as shownin FIG. 166 . FIG. 167 shows the completed repair. Graft 3020 is trappedbetween the exterior surface of anchor 3600 and first and secondlaterally opposed portions of the wall of socket 3032 and retained inposition by friction therefrom. Depth-limiting element 42001 remains inthe construct adjacent to the distal end of implant 42600, betweenimplant 42600 and graft 3020.

FIGS. 168 and 169 depict the distal portion of an embodiment whereindistally extending portions 52444 of distal tensioning element 52442 areformed of the distal portion of elongate metallic element 52447 depictedin FIGS. 170 and 171 . Elongate element 52447 has a distal end formingdistally extending portions 52444, and parallel proximally extendingelongate portions 52445 that are joined at proximal end 52449. Whenassembled for use as depicted in FIGS. 168 and 169 , elongate element52447 is positioned within the lumen of distal tensioning element 52442with distally extending portions 52444 aligned with slots 52441 in thedistal end of tensioning element 52442. The axial position of elongateelement 52447 within distal tensioning element 52442 may be maintainedby an elongate element such as a wire or suture with its distal endattached to proximal end 52449 of elongate element 52447, and itsproximal end cleated to the hub of the tensioning element.Alternatively, the proximal end of elongate element 52447 may beattached to the proximal end of distal tensioning element 52442 bywelding, brazing, adhesive or mechanical means. Distally extendingportions 52444 elastically and/or inelastically deform inwardly to allowdistal tensioning element 52442 to be withdrawn through the lumen ofimplant 52600.

INDUSTRIAL APPLICABILITY

As noted previously, there is a need in the art for simplified placementsystems and methods for tissue graft anchors by which the surgeon mayintroduce one or more sutures into a prepared socket in the boneytissue, apply tension to the sutures to advance a soft tissue graft to adesired location, and then advance an anchor into the bone whilemaintaining suture tension. The present invention addresses this need byproviding a system and method for the placement of an implant,especially a suture anchor, threaded, knotless or otherwise, that allowsthe surgeon to establish the graft position and, while maintaining thatposition, secure the anchor without changing the suture tension orcausing a shift in the graft position and furthermore, when the anchoris threaded, without spinning of the suture. The present inventionfurther addresses the need for double row fixation methods that allowfor each tissue-spanning suture to be individually tensioned prior to,and optionally after, if the original tension is deemed unsuitable,being removably affixed to the bone by an implant. Likewise, the presentinvention provides for the ready relocation of any anchor found to beunsuitable as well as the placement one or more additional implants asneeded to span the region with tensioned sutures. The present inventionalso provides off-axis socket drills and implant driving devices thatenable implantation in remote and difficult to access boney surfacesusing minimally invasive procedures. The present invention furtherprovides embodiments in which the relative axial movement between theinner tensioning device and outer driver device is physicallyconstrained, for example by means of springs, friction resistingelements, and the like, so as to allow for one-handed operation.Although described in detail with respect to ligament repairs, such asrepair of a torn rotator cuff, it will be readily apparent to theskilled artisan that the utility of the present invention extends toother tissues and injuries.

The disclosure of each publication, patent or patent applicationmentioned in this specification is specifically incorporated byreference herein in its entirety. However, nothing herein is to beconstrued as an admission that the invention is not entitled to antedatesuch disclosure by virtue of prior invention.

The invention has been illustrated by reference to specific examples andpreferred embodiments. However, it should be understood that theinvention is intended not to be limited by the foregoing description,but to be defined by the appended claims and their equivalents.

What is claimed:
 1. A method for affixing a soft tissue graft to a boney surface, said method comprising the steps of: a. providing a soft tissue graft characterized by a lateral edge and top and bottom surfaces; b. providing at least one elongate suture characterized by first and second segments; c. securing said first segment of said suture to said boney surface by means of a first implant inserted into said boney surface; d. positioning said soft tissue graft over said first implant; e. passing a first length of said suture that includes said second segment from said first implant over the top surface of said soft tissue graft, such that said second segment extends away from said first implant; f. preparing a socket in said boney surface at a predetermined location adjacent to said first implant either before or after step (e); g. establishing a desired tension in said first length of said suture that is sufficient to compress to the boney surface an area of the soft tissue graft that is disposed between said first implant and said predetermined location; and h. after said desired tension is established in accordance with step (g) and using only a second implant of one-piece construction, placing said second implant into said prepared socket so as to simultaneously fix the placement of said second segment of said suture and compress at least a portion of said first length of said suture between an outer surface of said second implant and a wall of said socket, whereby said desired tension in said first length of suture is maintained throughout step (g).
 2. The method of claim 1, wherein the predetermined location of said socket is medial to a lateral edge of said soft tissue graft.
 3. The method of claim 1, wherein the predetermined location of said socket is lateral to a lateral edge of said soft tissue graft.
 4. The method of claim 1, wherein said soft tissue graft is further secured to said target boney surface by repeating steps (e)-(h) using third and optionally fourth implants.
 5. The method of claim 4, wherein one of said second and third implants is positioned medial to the lateral edge of said soft tissue graft while the other is positioned lateral to the lateral edge of said soft tissue graft.
 6. The method of claim 1, wherein said method further comprises the step of adjusting the tension in said first length of suture after placement of said second implant.
 7. The method of claim 6, wherein said tension adjustment is achieved by: a. proximally retracting said second implant; b. adjusting the tension in said first length of suture; and c. distally advancing said second implant back into said socket until said second suture segment is adequately secured between the outer surface of said second implant and the wall of said socket and thus said first length of said suture is adequately tensioned so as to provide fixation to said soft tissue graft.
 8. The method of claim 1, wherein said method further comprises the step of repositioning said second implant in said prepared socket.
 9. The method of claim 8, wherein said repositioning step is achieved by: a. removing said second implant; b. forming a second socket in a second predetermined location; c. adjusting the tension in said first length of said suture; and d. distally advancing said second implant into said second socket until said second suture segment is adequately secured between the outer surface of said second implant and the wall of said second socket and thus said first length of said suture is adequately tensioned so as to provide fixation to said soft tissue graft.
 10. The method of claim 1, wherein said second implant is cannulated.
 11. The method of claim 10, wherein said second implant comprises an interference plug-type anchor.
 12. The method of claim 10, wherein said second implant comprises a threaded anchor.
 13. The method of claim 1, wherein said first implant is cannulated.
 14. The method of claim 13, wherein said first implant comprises an interference plug-type anchor.
 15. The method of claim 13, wherein said first implant comprises a threaded anchor.
 16. The method of claim 1, wherein in step (h), said second implant is placed in said prepared socket by means of a one-handed implant placement system comprising: a. a cannulated driver device comprising a proximal handle portion, an elongate tubular distal portion that defines a longitudinal axis of the system and includes an open distal end configured to receive said second implant, and at least one driver lumen extending from said proximal handle portion to said open distal end; b. an elongate insertion device that includes a rigid distal portion configured to receive said first length of suture; and c. an axial control assembly having a first constrained configuration and a second free configuration; wherein: i. said insertion device is slidably received within said at least one lumen of said driver device; ii. when said axial control assembly is in said first constrained configuration, the distal portion of said insertion device extends distally past a distal end of said second implant when coupled to said driver device so as to enable said insertion device distal portion to receive said first length of suture and relative axial movement between said driver device and said insertion device is precluded; and iii. when said axial control assembly is in said second free configuration, the driver device and implant move axially in a distal direction along the length of said rigid distal portion of said insertion device to thereby drive said implant into said socket while the insertion device is maintained in a fixed position. 